Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Phase: NA
Conditions: Hypothermia Neonatal
Sponsor: Boston Children's Hospital

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Study Title: 
Electricity-free Infant Warmer for Newborn Thermoregulation 
 
Principal Investigators: 
Evrard NAHIMANA MD, Leana May, DO MPH, Anne HANSEN MD 
 
Submission Date: 14 February 2015 
 
Co-Investigators:  
Peter DROBAC, MD  
 
Evodia DUSHIMIMANA MD 
Hema MAGGE MD MS 
Bethany HEDT-GAUTHIER, PhD  
Annie MICHAELIS, PhD 
Shashi BULUSWAR PhD  
 
Institutions:  
Rwandan Ministry of Health (MOH) 
Partners In Health-Inshuti Mu Buzima (PIH-IMB) 
Rwandan Biomedical Counsel (RBC) 
Boston Children's Hospital (BCH) 
Brigham and Women’s Hospital (BWH) 
Harvard Medical School (HMS) 
Institute for Transformative Technologies (ITT) 
 
Summary of Study (Synopsis) 
Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care is a safe and 
effective method of warming; however, it is not always feasible, and not possible in settings such as 
resuscitation or clinical instability. Electric warmers are the standard of care in developed countries, but 
are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often 
not feasible in settings without stable electricity. Through a multi-institutional collaboration, we have 
developed an electricity-free infant warmer. After laboratory based prototype testing for safety and 
efficacy, we aim to study the supervised use of the warmer under routine implementation conditions in a 
resource-limited setting. The primary aim of Phase 1 is to determine if the infant warmer is a safe, 
effective, usable and functional addition to KMC. This is planned in a convenience sample of patients in 
two district hospitals, one in a relatively warm environment, and one in a colder setting using quantitative 
methods and observer audits of usability and functionality. After determination of safety and effectiveness 
and making any necessary modifications to the warmer, Phase 2 aims to study the warmer in rural health 
centers and transport, as this is where we ultimately aim to use the electricity free devices due to the 
limited access to functioning and stable electricity in these settings. The primary aims are to assess the 
safety, efficacy, usability and functionality of the infant warmer in rural health centers during post-partum 
care, resuscitation/stabilization and on transport using the same methods as Phase 1. The second aim is to 
assess the perceived usability, functionality, and acceptability of the infant warmer as an addition to KMC 
in the health center setting from the perspectives of caregivers and health care providers using qualitative 
methods. The overall goal of the project is dissemination of the study results, and ultimately the infant 
warmer to the district and national level for key policy makers and stakeholders, as well as globally via 
publication.

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Table of Contents 
Executive Summary ................................................................................................................................. 1 
Background and Literature Review ....................................................................................................... 6 
Phase 1 Study 
2. Aims and Objectives .......................................................................................................................... 7 
3. Methods .............................................................................................................................................. 7 
3.1.1 Study description 
3.1.2 Study design 
3.1.3 Study Materials Safety 
3.1.4 Study site 
3.1.5 Study population 
3.1.6 Proposed intervention and Safety Considerations 
3.1.7 Main exposures, outcomes and confounders to be measured 
 
4. Selection of study population ........................................................................................................... 10 
4.1 Inclusion criteria 
4.2 Exclusion criteria 
4.3 Stop criteria 
4.4 Sampling 
4.5 Recruitment methods 
4.6 Subject enrollment 
4.7 Randomization 
 
5. Study procedures .............................................................................................................................. 11 
5.1 Procedures at enrollment and data collection 
5.2 Follow-up 
5.3 Measurement of exposures, outcomes and confounders 
5.4 Study Limitations 
5.5 Lab measures 
5.6 Sample size 
5.7 Data management 
5.8 Proposed analysis 
 
Phase 2 Study 
2. Aims and Objectives ........................................................................................................................ 13 
Aim 1 
3. Methods ............................................................................................................................................ 13 
 
3.1.1 Study description 
 
3.1.2 Study design 
 
3.1.3 Study Materials Safety 
 
3.1.4 Study site 
 
3.1.5 Study population 
 
3.1.6 Proposed intervention and Safety Considerations 
 
3.1.7 Main exposures, outcomes and confounders to be measured 
4. Selection of study population ................................................................................................. 16 
4.1 Inclusion criteria 
4.2 Exclusion criteria 
4.3 Stop criteria 
4.4 Sampling 
4.5 Recruitment methods 
4.6 Subject enrollment 

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4.7 Randomization 
5. Study procedures .................................................................................................................... 17 
5.1 Procedures at enrollment and data collection 
5.2 Follow-up 
5.3 Measurement of exposures, outcomes and confounders 
5.4 Study Limitations 
5.5 Lab measures 
5.6 Sample size 
5.7 Data management 
5.8 Proposed analysis 
    Aim 2 
3. Methods .................................................................................................................................. 18 
3.1.1 Study description 
3.1.2 Study design 
3.1.3 Study site 
3.1.4 Materials and Safety 
3.1.5 Study population 
3.1.6 Proposed intervention 
3.1.7 Main exposures, outcomes and confounders to be measured 
 
4. Selection of study population ................................................................................................. 19 
4.1 Inclusion criteria 
4.2 Exclusion criteria 
4.3 Stop criteria 
4.4 Sampling 
4.5 Recruitment methods 
4.6 Subject enrollment 
4.7 Randomization 
 
5. Study Procedures  ................................................................................................................... 20 
5.1 Procedures at enrollment 
5.2 Follow-up 
5.3 Measurement of exposures and confounders 
5.4 Measurement of outcome 
5.5 Lab measures 
5.6 Sample size 
5.7 Data management 
5.8 Proposed analysis 
Phases 1 & 2 
6. Ethical considerations ....................................................................................................................... 21 
6.1 Risks and discomforts 
6.2 Potential benefits 
6.3 Confidentiality 
6.4 Informed consent 
6.5 Ethical approval 
 
7. Logistics and Dissemination of Results............................................................................................ 22 
7.1 Distribution of responsibilities 
7.2 Timetable 
 
Appendices 
Appendix A: Infant Warming Blanket Durability, Performance and Safety Testing………….……..24 

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Appendix B: Infant Warmer Setup ....................................................................................................... 27 
Appendix C: Budgets ........................................................................................................................... 28 
Appendix D: Caregiver Consent Form for Warmer Use (Phases 1 & 2)  ............................................ 30 
Appendix E: Nurse Consent Form for Warmer Use (Phases 1 & 2)  ................................................... 33 
Appendix F: Qualitative Interview Consent Form for Nurses and Caregivers (Phase 2)  .................... 36 
Appendix G: Infant Warmer Data Collection Form During Infant Warmer Use ................................. 38 
Appendix H: Infant Warmer Data Collection Form (Phase 1)  ............................................................ 40 
Appendix I: Infant Warmer Data Collection Form (Phase 2)............................................................... 42 
Appendix J: Infant Warmer Data Collection Form (Phase 2)  ............................................................. 46 
Appendix K: Infant Warmer Qualitative Interviews: Purposive Sampling Matrix .............................. 51 
 
References ............................................................................................................................................... 52 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Background: Reaching Millennium Development Goal 4 is proving elusive in many countries, 
primarily due to lack of progress in decreasing neonatal mortality. Of the 2.9 million infants who die in 
the first month of life, 1 million die in their first day.1 Reductions in the neonatal mortality must address 
this high proportion of early deaths. Thermoregulation is a critical component of the care of all newborn 
infants after birth, and is especially challenging in those born preterm, growth restricted, or ill.  Ability to 
provide a warm environment through immediate drying and wrapping and prompt recognition and 
treatment of hypothermia is estimated to avert up to 40% of neonatal deaths. 2 Beyond survival, providing 
adequate warmth to infants decreases metabolic demand, with a 22% reduction in oxygen consumption in 
warmed term infants compared to controls.3 Therefore supporting thermoregulation also promotes 
nutrition and weight gain.  
The current recommended method of providing ongoing thermoregulation for low birth weight (LBW) 
newborns in resource-limited settings is Kangaroo Mother Care (KMC). This entails placing an infant on 
the mother’s chest for continuous skin-to-skin contact until the infant is mature enough to maintain a 
stable, normal temperature.  KMC is a proven method of thermoregulation that saves infants’ lives, and 
has been reported to be as efficacious as an incubator to provide thermoregulation for infants > 28 weeks 
gestation.4 However KMC has important limitations: when an infant is ill, the position on the mother’s 
chest is not conducive to providing medical assessments and interventions. If the mother dies during 
childbirth or is too ill post-partum, she is unable to provide KMC. If there are multiple gestations the 
mother cannot provide KMC for all of her newborns. Finally, many mothers have other responsibilities 
that prevent them from being able to provide continuous KMC, and some local customs and cultures 
create a barrier to effective promotion of KMC. Therefore, there is a need for a safe and affordable 
alternative to supplement KMC in these conditions.  
 
The non-electric infant warmer proposed for study has been developed by the  Institute for 
Transformative Technologies (ITT), one of the world’s leading academic non-profit research institutions, 
with field-based input by clinical partners at Boston Children’s Hospital, Partners In Health, and the 
Rwanda Ministry of Health to ensure that the developed product is informed by input from intended end-
users. Members of the study team have no financial interest in the ultimate success or failure of the 
proposed product.  
 
The only other currently available low-cost warmer that we know of, “Embrace,” has a few notable 
differences from the proposed warmer. It uses similar phase-change material but covers the infant 
entirely, limiting exposure of the infant if unstable for resuscitation/stabilization. Additional 
disadvantages are that it costs approximately 10 times more than the device that we are developing 
(around $200 vs. $20 USD). Embrace has European Inspection (EI) approval. To test the proposed 
device, the laboratory used similar EI protocols to that used by “Embrace” for safety and performance 
assessment whenever possible. When no standard existed, a protocol was created with guidance from 
technical experts with experience in medical product design. Prior to conducting this clinical study, the 
proposed infant warmer has been extensively tested for safety, thermal performance, and durability by 
ITT, to ensure that it is safe for patient use (See Section 3 and Appendix A). Importantly, a focus has been 
maintained on ensuring rigorous laboratory testing protocols prior to study with human infants to 
minimize any potential harm to patients. However, no “infant” laboratory model will be able to replicate 
the living system in which the warmer studied is studied in relationship to real infants whose metabolism 
generates heat (as opposed to non-living objects that can only lose heat). Furthermore, given the 
variations in usability and functionality that are introduced when placed in a routine environment, study in 
infants when used in a setting where this technology is aimed for ultimate use is necessary.  
 
The infant warmer is modeled on a heating pad, filled with a phase change material that changes from 
liquid to solid at skin temperature (approximately 37oC). It is heated by immersion in hot water. Once it 
cools to the phase change temperature between 37-38oC, it stays at this temperature for many hours. It is 
equipped with a color indicator that provides the user with a simple and clear means of knowing when it 

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has adequately cooled to a temperature in which it is safe to begin use. The safe/effective use zone is from 
38 degrees down to 35 degrees (8), with the goal of providing similar warmth to that provided by KMC. 
 
Each conceptual component of the safety and efficacy of this proposed system has been tested in a 
controlled setting. Placing premature infants on a heating pad in the delivery room has become an 
approved, recommended option to maximize thermoregulation prior to admission to a Neonatal Intensive 
Care Unit (NICU).  Combining the rigorous safety and efficacy testing of the approved delivery room 
pads5 with the knowledge that long-term use continues to be safe and efficacious in the smaller sample 
size of those exposed to the water-heated mattress pad,6 as well as the proven benefits of KMC strongly 
supports the overall concept of using heating pads for thermoregulation in neonatal care.7  
 
This simple, water-heated thermoregulation device has the potential to overcome many of the limitations 
encountered by current thermoregulation alternatives. It will be simple and reliable to heat even in remote 
settings, needing only on hot water instead of electrical or solar power. It is made out of sturdy material 
that can be cleaned and re-used many times. The cost of the heating pad is anticipated to be 
approximately US$20 per pad, making it less expensive than options currently available. Basic newborn 
care and infant warmer instructions will be printed on the device in simple language with illustrations. 
The use of widely available, nontoxic materials allows the heating pad to be fully manufactured locally.  
 
We propose to conduct a two-phase study. Phase 1 will assess the safety, efficacy, usability and 
functionality of the infant warmer in the hospital setting. If Phase 1 results demonstrate sufficient safety, 
efficacy, usability, and functionality and results are approved by the RNEC committee, we will proceed 
with Phase 2 of the study. The second phase will assess safety and efficacy in the health center setting and 
in transport, and usability, functionality, and acceptability in the health center setting.   
 
PHASE 1 STUDY 
 
2. Aims and Objectives: To determine if the infant warmer is a safe, effective, usable and functional 
addition to KMC. Our primary hypothesis is that the infant warmer is a safe, effective, usable and 
functional means to achieve and maintain euthermia when KMC is not possible or inadequate.   
 
3. Methods 
 
3.1.1 Study description: Intervention study using clinical observation to assess safety, efficacy, 
usability and functionality. 
 
3.1.2 Study design:  Prospective study in hospital setting assessing safety and efficacy of infant 
warmer based on clinical observation, and usability and functionality based on observer audits.  
 
3.1.3 Study materials safety: The newly developed infant warmer has been extensively assessed 
for safety, thermal performance and durability prior to use with humans. US Food and Drug 
Administration (FDA) guidance was used as a gold standard when guidance existed. All 
products sold in the US must adhere to industry standards for safety, determined by the FDA. 
Per FDA guidelines for testing biocompatibility of pre-market medical devices, the materials 
used in the manufactured device will be tested according to International Standard ISO-10993, 
116 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.”8 The study 
device’s biological safety has been ensured by selecting materials that are either FDA approved 
or have been previously been tested and certified safe (tested negative).  
        
3.1.4 Study site: We will partner with PIH-IMB supported District Hospitals in Rwanda. The study 
will take place in the neonatal and maternity wards at these hospitals. Study sites will include a 
district hospital in a relatively cold region and one in a relatively warmer region of the country. 

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This will likely include Butaro and Kirehe District Hospitals. Preliminary conversations with 
hospital leadership regarding their willingness to host these studies has been encouraged, 
however, the formal request for hospital participation will come from the MCH Director upon 
protocol finalization. PIH-IMB has strong partnerships with the participating hospitals and 
sufficient research infrastructure to assist in data collection, entry and analysis. 
 
3.1.5 Study population: The target study population is infants who meet criteria for KMC 
(particularly preterm and LBW infants at risk for hypothermia) for whom KMC is not able to 
be provided or is inadequate. Inclusion and exclusion criteria have been designed to identify 
this population. We aim to enroll all infants during the data collection period scheduled hours 
who meet inclusion criteria and have no exclusion criteria (see sections 4.1 and 4.2).  
 
3.1.6 Proposed Intervention and Safety Considerations: In line with current recommended 
practice, the mother will be encouraged to provide KMC whenever possible. If the infant’s 
temperature is not rising by ½ degree per hour with KMC alone, the infant warmer will be 
offered as an addition by the study staff. Heat can be provided by placing the infant on the 
infant warmer as it lies flat or by placing it over the infant’s back while the mother provide 
KMC. These two options allow the degree of heat provision to be modified based on the degree 
of prematurity, low birth weight and hypothermia. If the mother is not available for KMC at 
any time, the infant will be warmed exclusively with the infant warmer. Bundling with clothes 
will only be added in addition to the warmer per caregiver/provider preference, as it is not 
medically necessary but often a parental desire. Because this would be expected to alter the 
effect of the infant warmer, bundling will be recorded on the data collection sheet. Temperature 
measurement of the infant, warmer, and ambient air will be measured every 15 minutes for the 
first hour, and then hourly and as needed for the remainder of use or until warmer endpoint is 
reached (warmer temperature below 36 degrees or phase-change material hardens [soft, 
semisoft, or hardened]). 
 
If an appropriate electric warming source (warming table or incubator) is available and an 
infant is determined to meet the inclusion criteria for the study on the basis of hypothermia with 
failure of or unavailable KMC, heat should be provided by the electric warming source until 
consent can be obtained for the study and the infant warmer can be prepared for use. Infants, 
including stable preterm infants as outlined by inclusion and exclusion criteria, are eligible for 
use of the infant warmer every time they meet the inclusion criteria, which may be multiple 
times during their hospital stay. Each infant warmer unit will have an identification number 
assigned to it which will be clearly displayed on the unit. Each exposure of the infant to a 
warmer will be considered a separate exposure in the analysis. A warmer may be used on 
multiple infants. The infant warmer unit identification number will be tracked on the data 
collection form so that sub-analysis of patients using a specific infant warmer unit may be done. 
 
Once the infant is receiving warmth from the non-electric infant warmer, if an electric heat 
source is available and the infant meets any of the stop criteria outlined below in section 4.2, 
the infant will be taken off of the non-electric infant warmer, and given heat via the electric 
heat source. If the infant is ever considered to be too severely ill by the medical team to be 
safely cared for in the non-electric infant warmer, the infant should be transferred to the electric 
warming table.     
 
Though the duration of heat provision by the warmer will vary based both on the ambient 
temperature, and that of the infant, it would not be expected to stay within usable range for 
more than six hours. Therefore, it is expected that there will be not more than 4 measurements 
in hour 1 and 5 additional temperature measurements of the infant, the warmer, and the ambient 
air. The warmer will be removed once its temperature drops below 36 degrees, and/or the 

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phase-change material begins to harden. The method of thermoregulation and the addition of 
KMC and or bundling will be noted on the data collection sheet whenever it is changed. 
Generally, all of the data will be collected by the study manager; however, if there are 2 or 
fewer hourly measurements left at the end of business hours, the study manager may ask the 
nurse to voluntarily take the remaining 2 measurements. New subject recruitment will end 4 
hours prior to the end of the Study Manager work day so as to avoid incomplete data and 
unobserved use greater than 2 hours.  
 
In addition to the specific measurements collected for infants enrolled in the study, the study 
manager will work with the nurse to assess baseline patient temperature monitoring is being 
performed on all neonates throughout the neonatal unit to promote basic quality of care for all 
sick infants. According to the Rwandan national protocol infants are to be assessed every 3 
hours with documentation. 
 
Consent procedures (see also section 6, Ethical Considerations section) and data collection will 
be performed by study managers. Consent will be obtained from the mother as highest priority. 
If the mother is not physically co-located with the baby (ie, in maternity, while the baby is in 
neonatal) consent will be obtained from that father. Consent will be read orally to the 
caregiver(s) and written signature or mark (Appendices D and E). It will be obtained at the time 
that the infant is identified for study eligibility. If eligibility is anticipated prenatally, the 
parents will only be consented if able (not in advanced stage of labor or critically ill). 
 
If illiterate but cognitively competent, the informed consent will be read to the family, and the 
family is encouraged to ask questions. This process will occur with a witness present. In this 
case, the witness is to observe the entire process, not just the signature. The consenting parent 
will affix a signature to or make an "X" on the consent document. The witness will sign and 
date the consent document, and is to document, in writing, that the process took place and that 
the subject/family member voluntarily consents to participate. 
 
A study manager, with A1 or A0 clinical training and proficiency in the Rwandan national 
neonatal care protocol, research and data management experience, and relevant training in 
research ethics and confidentiality will be hired to supervise the study in each district hospital. 
The study managers will work in close collaboration with the Ministry of Health staff in their 
respective maternity and neonatal units.  
 
Nursing staff will be oriented to the study and trained in preparation and use of the warmer 
during appointed meeting times assigned by the hospital leadership. These sessions will include 
familiarizing and training nurses on proper and safe preparation and application of the warmer, 
including when to remove the warmer, and proper cleaning and storage. Training will include 
nurses demonstrating their competencies, under direct observation, prior to use in the neonatal 
unit to the study manager. The study manager will be available to answer any questions about 
usage.  
 
If the study manager observes any deviation from recommended infant warmer use that raises a 
safety concern, the study manager will intervene to discuss this with the nurse and prevent 
unsafe use of the warmer. For example if the nurse is preparing to put the infant on the warmer 
before the color indicator shows that the warmer is at a safe temperature to begin use, the study 
manager will alert the nurse to this safety concern.  In this circumstance, the study manager 
would note on the data collection form that improper use of the infant warmer was attempted, 
so that the study will be able to calculate the frequency of usage mistakes. 
 
3.1.7. Main exposures, outcomes and confounders to be measured 

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Exposures: The exposure is the method of thermoregulation: infant warmer with KMC or 
alone. Maximum exposure from here on out will be defined as the infant warmer plus KMC, if 
KMC is available. We will also document bundling of the infant.  During an observed clinical 
encounter, it is possible for a infant to have multiple exposures.(i.e., using the infant warmer at 
multiple independent occurrences). 
 
Outcomes:  
a) Efficacy:  
o Minimum patient temperature achieved during use  
 Target: at least 90% of encounters will have patient temperature > 36.0oC for all 
measurements during encounter. If the infant’s initial temperature is below 36.0 oC, 
one hour on the infant warmer will be allowed for every half degree below 36.0 
before categorizing temperature as below minimum acceptable value. Patient 
temperature will be measured with a standard thermometer taken in the patient’s 
axilla. 
o Duration that temperature of infant warmer is within the goal  
 Target: With at least 95% of encounters, infant warmer maintains temperature 
between 35 and 38 degrees for 4 hours or more. Arrival at 38 degrees will be 
determined by a color indicator. Once the warmer has cooled to 38 degrees, the 
temperature of the warmer will be determined every 15 minutes for the first hour, 
then hourly by the study manager with the use of a digital thermometer with a 
thermistor probe.  
 
b) Safety: 
o Maximum patient temperature achieved during use  
 Target: at least 95% of encounters will have all measurements of patient temperature 
< 37.5oC. In order to protect patient safety, if infant’s temperature is > 37.5oC, infant 
will be taken off of warmer. 
o Presence of skin irritation (abrasion, burns). Of note, it would be extremely unlikely for a 
burn to occur, as the infant warmer has a built-in color indicator to clarify when the 
warmer has cooled adequately for safe use. A primary purpose of the infant warmer is to 
avoid the burns that can occur with the current practice (though not officially endorsed) 
option of placing heated objects such as water bottles or water filled gloves in direct 
contact with the infants’ skin, or improperly managed electric warmers and incubators. 
 Target: Fewer than 5% of infants with presence of skin irritation 
 
c) Usability: 
o Observer audit of usability:  
The Study Manager will assess for correct application of warmer. This will be assessed by a 
yes/no questionnaire with list of qualitative findings of any incorrect applications (see 
questionnaire tool in Appendix). These will include assessment of the time taken for 
preparation of the warmer, whether the infant is placed in the warmer and removed from the 
warmer at the indicated temperatures, and whether the warmer is appropriately cleaned with 
soap and water.  
 
Of note, safety of the patient will be protected by the Study Manager who will intervene 
prior to any unsafe use of the warmer that is observed (see section 3.1.5).  
 
d) Functionality:  
o Observer audit of functionality:  

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 The Study Manager will assess if the warmer material demonstrates any breakdown 
or other change 
 
Confounders:  Infant’s degree of hypothermia, gestational age and weight, ambient 
temperature (relevant for infant warmer efficacy), bundling of infant, and use of KMC. 
 
4. Selection of study population 
 
4.1 Inclusion criteria: Any infant with the following criteria for whom caregiver not available for 
KMC, or KMC is not adequate (less than ½ degree Celsius per hour rise in temperature).  
1) axillary temperature < 36oC and ≥35oC 
1a) If an electric warmer is available and the infant’s temperature is < 35 oC, then the infant 
would start by being warmed on the electric warmer until the infant’s temperature reaches 36 
oC, then can start non-electric infant warmer use   
2) Infants at-risk for hypothermia (criteria: estimated post-menstrual age of < 35 weeks or 
current body weight of < 2.5 kg)  
 
4.2 Exclusion Criteria:  
1) Any infant whose family is unwilling to consent to study.  
2) Mothers who are critically ill at the time of infant eligibility or deemed not medically stable 
by nursing staff to be approached for consent.  
3) Any infant with a contraindication to KMC (medical instability) and electrical heating source 
available. 
4) Any infant with initial temperature < 35oC and electrical heating source available. 
5) Infants within the first hour of admission to neonatal unit or first hour of life in maternity. 
6) Infants requiring phototherapy 
7) Infants with significant skin condition 
8) Infants with HIE  
 
4.3 Stop Criteria: If an electric heating source is available, the infant will be taken off of the study 
and warmed with an appropriate source of electric heat if the infant: 
1) Is hypothermic and temperature decreases on any measurement 
2) Is hypothermic and temperature does not begin to rise within 30 minutes 
3) Is hypothermic and not heating at a rate of > ½ oC per hour until temperature is 
 
>36.5oC 
4) Has a temperature that falls below 36 oC despite maximum exposure to the heat source 
5) Is ever considered to be too severely ill by the medical team to be safely cared for in the non-
 
electric infant warmer.  
6) The warmer will be removed once its temperature drops below 36 degrees, and/or the phase 
change material begins to harden.  
 
4.4 Sampling: Continuous enrollment at PIH-IMB-supported district hospitals as described in 
section 3.1.5.  
 
4.5 Recruitment Methods: Study manager will circulate between the neonatal and maternity units 
to identify eligible patients following the inclusion/exclusion criteria described above. Once a 
patient has been identified as eligible, the study manager will approach the caregiver for 
consent. If consent is given, the study manager will then consent the treating nurse and inform 
him/her to begin preparing the infant warmer for use.   
 
4.6 Subject enrollment: All infants will be assigned a code by the order in which they are 
consented to participate. A password-protected file matching consent form code to 

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identification code will be kept on a password-protected computer equipped with antivirus 
software. The identification code will be marked on the patient’s consent and data collection 
form.  The completed consent and data collection forms will be locked in a filing cabinet in a 
locked room. 
  
4.7 Randomization: None. 
 
 
5. Study Procedures 
 
5.1 Procedures at enrollment and data collection: Infants meeting criteria for KMC will be 
treated according to the thermoregulation chapter of the Rwanda MOH Neonatal Protocols, 
starting with initiation of KMC. Once KMC is initiated and if the patient meets inclusion 
criteria with no exclusion criteria, the caregiver will be approached for possible enrollment in 
study. If caregiver consents, data collection will commence by a data officer. If the infant’s 
temperature with KMC alone does not rise by at least ½ degree per hour, addition of infant 
warmer will be offered. Whenever the consented mother is unavailable for KMC, the infant will 
be placed on the infant warmer exclusively. Temperature measurement of the infant, warmer, 
and ambient air will be measured every 15 minutes for the first hour, and then hourly and as 
needed for the remainder of use or until warmer endpoint is reached (warmer temperature 
below 36 degrees or phase-change material hardens). See also 3.1.6 for details of role of 
electric heat source for study patients and 4.3 for stopping procedures for study.  
 
5.2 Follow-up:  None 
 
5.3 Measurement of exposures, outcomes and confounders: Exposure variable of infant warmer 
will be documented in the data collection form (see Appendix F). Whenever the mode of 
thermoregulation changes, the mode and time of change will be documented on the data 
collection form. Data regarding potential confounders (see section 3.1.7) will also be collected 
on the data collection form.   
 
Infant’s temperature, warmer temperature, and ambient temperature will be documented per 
protocol. The study manager will document at every application whether the infant warmer was 
applied correctly.  The study manager will document at the end of every infant encounter 
whether the warmer is properly cleaned and assessed for any visible signs of material 
breakdown or change. 
 
5.4 Study Limitations:  This is not a randomized-controlled trial, and does not aim to prove that 
this method is more effective than KMC. Rather, this is a safety and efficacy trial and we aim to 
measure the safety and efficacy of the device when used to complement KMC through an 
observational study. Potential confounders may affect the generalizability of the results. 
Expectation bias may be of issue in that the study managers could opt to document the observer 
audit favorably under the non-electric infant warmer because they know that the warmer is 
something that PIH-IMB is involved in developing. Training will be specifically conducted 
with the study manager to minimize this potential bias.  
 
5.5 Lab measures: none 
 
5.6 Sample Size: We will power our study for the primary efficacy outcome, minimum temperature 
achieved.  We aim for 90% of infants exposed to the infant warmer to achieve a temperature of 
at least 36.0o C. We aim to have 90% power to detect if the percent achieving the minimum 
temperature is 80% or less. For this one-sided test at the α=0.05, a sample size of 102 infants is 
sufficient. 

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5.7 Data Management: A Rwanda-based study manager will be hired and trained to recruit  
 
patients, consent families (see Ethical Considerations section for details), collect data, enter data, 
 
and assist with data analysis. Study supervisors will audit 10% of data transcribed from paper 
 
forms to an electronic Excel database to assure data quality (e.g., completeness and concordance 
 
between paper forms and electronic database). If the completeness and concordance is less than 
 
95% in the database, then the data from paper forms will be double-entered into the database. The 
 
completed consent and data collection forms will be locked in a filing cabinet in a locked room. 
 
All infants will be assigned a participant identification number by the order in which they are 
 
consented to participate. This participant ID will be on data collection forms and consent forms. 
 
De-identified data will be entered into an excel password-protected database for analysis. A 
 
separate password-protected linking file matching this ID to identifiers on the data collection 
 
forms (facility ID and date of birth) will be kept on a password-protected computer equipped with 
 
antivirus software for a total period of 2 years after the end of study completion. At that time the 
 
linking file and data collection forms will be destroyed. There will be no contact with families 
 
outside of the hospital stay. 
 
5.8 Proposed analysis: We will estimate the proportion of exposures to the infant warmer in which: 
 Minimum desired temperature of the infant is achieved (allowing one hour on infant 
warmer for every half degree below 36.0oC before categorizing temperature as below 
minimum temperature). 
 The maximum desired temperature of infant is not exceeded.   
 Infant skin has no visible skin irritation. 
 The warmer is applied to the infant correctly. 
 
Each use of the infant warmer will be included in the analysis. Because it is possible that an 
infant have multiple exposures to the infant warmer during an encounter, we will estimate the 
variance of these measures accounting for clustering on this level and adjust the confidence 
intervals accordingly.  The estimates above will be compared to the goals described in section 
3.1.6.   
 
We will estimate the proportion of infant encounters where: 
 The warmer maintains temperature in desired range of 36 – 40 degrees for 4 hours or 
more. 
 The warmer is properly cleaned. 
 The warmer shows no visible signs of deterioration. 
 
We will conduct a secondary analysis of the subgroup that received both KMC and infant 
warmer thermoregulation to compare the efficacy of these alternatives to each other.  
 
PHASE 2 STUDY 
 
If the Phase 1 study in the hospital setting shows that the infant warmer is a safe, effective, usable and 
functional addition to KMC, we would then move to Phase 2 of our study in which we will assess the 
safety and efficacy in the health center and transport settings and the usability, functionality and the 
acceptability in the health center setting using quantitative and qualitative methods. Phase 1 results will be 
presented to RNEC for approval prior to proceeding to Phase 2.  
 
2. Aim and Objectives:  
 

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1) To assess the safety, efficacy, usability and functionality of the infant warmer in rural health centers 
during post-partum care, resuscitation/stabilization and on transport (the target settings for ultimate use) 
using the same methods as Phase 1. 
 
2) To assess the perceived usability, functionality, and acceptability of the infant warmer as an addition to 
KMC in the health center setting from the perspectives of caregivers and health care providers using 
qualitative methods. 
 
Aim 1 
 
3. Methods 
 
3.1.1 Study description: Intervention study using clinical observation to assess safety, efficacy, 
usability and functionality. 
 
3.1.2 Study design:  Prospective study in health center and transport settings assessing safety and 
efficacy of infant warmer based on clinical observation, usability and functionality based on 
observer audits.  
 
3.1.3 Study materials safety: The newly developed infant warmer has been extensively assessed 
for safety, thermal performance and durability prior to use with humans. US Food and Drug 
Administration (FDA) guidance was used as a gold standard when guidance existed. All 
products sold in the US must adhere to industry standards for safety, determined by the FDA. 
Per FDA guidelines for testing biocompatibility of pre-market medical devices, the materials 
used in the manufactured device will be tested according to International Standard ISO-10993, 
116 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.”8 The study 
device’s biological safety has been ensured by selecting materials that have been previously 
been tested and certified safe (tested negative).  
 
3.1.4 Study site: We will partner with PIH-IMB-supported District health centers in Rwanda for 
the testing sites (as described in Phase 1). We plan to sample two health centers in Burera 
district and two from Kirehe District after discussions with District leadership and 
determination of their interest in participation and authorization.  
 
Including two districts allows for the inclusion of sites with varying ambient temperatures 
(colder district and warmer district). Using two sites per district allows us to sample a site with 
electricity and ideally one without electricity readily available. 
 
3.1.5 Study population: The target study population is infants who meet criteria for KMC 
(particularly preterm and LBW infants at risk for hypothermia), not able to be provided or is 
inadequate. In Phase 2, we also include infants for whom KMC is contraindicated, such as 
those requiring resuscitation after delivery. Infants requiring transport will also be eligible.  
Inclusion and exclusion criteria have been designed to identify this population. We aim to 
enroll all infants who meet inclusion and with no exclusion criteria for study (see sections 4.1 
and 4.2).  
 
3.1.6 Proposed Intervention and Safety Considerations: In line with current recommended 
practice, the mother will be encouraged to provide KMC whenever possible. If the infant’s 
temperature is not rising by ½ degree per hour with KMC alone, the infant warmer will be 
offered as an addition by the study staff. Heat can be provided by placing the infant on the 
infant warmer as it lies flat or by placing it over the infant’s back while the mother provide 
KMC. These two options allow the degree of heat provision to be modified based on the degree 

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of prematurity, low birth weight and hypothermia. If the mother is not available for KMC at 
any time, the infant will be warmed exclusively with the infant warmer. Bundling with clothes 
will only be added in addition to the warmer per caregiver/provider preference, as it is not 
medically necessary but often a parental desire. Because this would be expected to alter the 
effect of the infant warmer, bundling will be recorded on the data collection sheet. Temperature 
measurement of the infant, warmer, and ambient air will be measured every 15 minutes for the 
first hour, and then hourly and as needed for the remainder of use or until warmer endpoint is 
reached (warmer temperature below 36 degrees or phase-change material hardens [soft, 
semisoft, or hardened]).  
 
If an appropriate electric warming source (warming table or incubator) is available and an 
infant is determined to meet the inclusion criteria for the study on the basis of hypothermia with 
failure of or unavailable KMC, heat should be provided by the electric warming source until 
consent can be obtained for the study and the infant warmer can be prepared for use. Infants, 
including stable preterm infants as outlined by inclusion and exclusion criteria, are eligible for 
use of the infant warmer every time they meet the inclusion criteria, which may be multiple 
times during their hospital stay. Each infant warmer unit will have an identification number 
assigned to it which will be clearly displayed on the unit. Each exposure of the infant to a 
warmer will be considered a separate exposure in the analysis. A warmer may be used on 
multiple infants. The infant warmer unit identification number will be tracked on the data 
collection form so that sub-analysis of patients using a specific infant warmer unit may be done. 
 
Ideally, consent for study participation would be obtained and the non-electric infant warmer 
will be being warming in the thermos of hot water while the mother in in labor. The infant 
warmer would then be taken out of the thermos to begin cooling about one hour prior to 
anticipated delivery in order to adequately cool for use immediately after delivery. However, if 
an appropriate electric warming source (warming table or incubator) is available and an infant 
is determined to meet the inclusion criteria for the study but the non-electric infant warmer is 
not available or consent has not been obtained, then heat should be provided by the electric 
warming source until the infant warmer can be prepared for use and consent can be obtained.   
 
Once the infant is receiving warmth from the non-electric infant warmer, if an electric heat 
source is available and the infant meets any of the stop criteria outlined below in section 4.2, 
the infant will be taken off of the non-electric infant warmer, and given heat via the electric 
heat source. If the infant is ever considered to be too severely ill by the medical team to be 
safely cared for in the non-electric infant warmer, the infant should be transferred to the electric 
warming table.     
 
Though the duration of heat provision by the warmer will vary based both on the ambient 
temperature, and that of the infant, it would not be expected to stay within usable range for 
more than six hours. Therefore, it is expected that there will be not more than 4 measurements 
in hour 1 and 5 additional temperature measurements of the infant, the warmer, and the ambient 
air. The warmer will be removed once its temperature drops below 35 degrees, indicated by a 
change in the temperature indicator. The method of thermoregulation and the addition of KMC 
and or bundling will be noted on the data collection sheet whenever it is changed.  
 
Generally, all of the data will be collected by the study manager; however, if there are 2 or 
fewer hourly measurements left at the end of business hours, the study manager may ask the 
nurse to voluntarily take the remaining 2 measurements. New subject recruitment will end 4 
hours prior to the end of the Study Manager work day so as to avoid incomplete data and 
unobserved use greater than 2 hours.   
 
 

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Additional use relevant to the health center setting includes use of the infant warmer when 
KMC is contraindicated or not feasible, in particular during neonatal resuscitation/stabilization 
and patient transport when an electric warmer is unavailable. Therefore, there are three main 
clinical settings in which we would like to assess the warmer performance: routine post-partum 
care, resuscitation/stabilization, and patient transport. 
 
As in Phase I, consent and data collection will be performed by the study manager. Since the 
infant warmer will be studied during neonatal resuscitation and transfer as well as routine post-
partum care, potentially eligible mothers will be approached upon admission to the health 
center for possible enrollment in study. Study managers will work with the nurse to identify 
women for potential enrollment (ie, anyone admitted to maternity at the health center). Once a 
patient has been identified as eligible, the study manager will approach the caregiver for 
consent. As in Phase 1, consent will be obtained from the mother as highest priority.  
 
Consent will be read orally to the caregiver(s) and written signature or mark (Appendices D and 
E). It will be obtained at the time that the infant is identified for study eligibility. If eligibility is 
anticipated prenatally, the parents will only be consented if able (not in advanced stage of labor 
or critically ill). If illiterate but cognitively competent, the informed consent will be read to the 
family, and the family is encouraged to ask questions. This process will occur with a witness 
present. In this case, the witness is to observe the entire process, not just the signature. The 
consenting parent will affix a signature to or make an "X" on the consent document. The 
witness will sign and date the consent document, and is to document, in writing, that the 
process took  place and that the subject/family member voluntarily consents to participate. 
 
If consent is given, the study manager will then consent the treating nurse and inform him/her 
to begin preparing the infant warmer for use.  Data collection will commence by a study 
manager if patient ultimately meets eligibility requirements. 
 
 
 Generally, all of the data will be collected by the study manager; however, if there are 2 or 
fewer hourly measurements left at the end of business hours, the study manager may ask the 
nurse to voluntarily take the remaining 2 measurements. New subject recruitment will end 4 
hours prior to the end of the Study Manager work day so as not to avoid incomplete data and 
unobserved use greater than 2 hours.   
 
Actual preparation and application of the warmer will be performed by the nurse in order to 
assess usability. Nursing staff will be oriented to the study and trained in preparation and use of 
the warmer during morning staff meetings. The study manager will observe all usage of the 
warmer and be available to answer any questions about usage.  
 
If the study manager observes any deviation from recommended infant warmer use that raises a 
safety concern, the study manager will intervene to discuss this with the nurse and prevent 
unsafe use of the warmer. For example if the nurse is preparing to put the infant on the warmer 
before the color indicator shows that the warmer is at a safe temperature to begin use, the study 
manager will alert the nurse to this safety concern.  In this circumstance, the study manager 
would note on the data collection form that improper use of the infant warmer was attempted, 
so that the study will be able to calculate the frequency of usage mistakes. 
 
In line with current recommended practice, the mother will be encouraged to provide KMC 
whenever possible. If the infant’s temperature is not rising by ½ degree per hour with KMC 
alone, the infant warmer will be offered as an addition by the study staff. If the mother is not 

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available for KMC at any time, the infant will be warmed exclusively with the infant warmer. 
Infants’ temperature will be measured every hour and as needed.  
 
3.1.7. Main exposures, outcomes and confounders to be measured 
Exposures: The exposure is the method of thermoregulation: infant warmer with KMC or 
alone. Maximum exposure from here on out will be defined as the infant warmer plus KMC, if 
KMC is available. We will also document bundling of the infant.  During an observed clinical 
encounter, it is possible for an infant to have multiple exposures. (i.e., using the infant warmer 
at multiple independent occurrences). 
 
Outcomes: This phase of the study will assess the same outcomes in safety, efficacy, usability 
and functionality as described previously in Phase 1. This will be assessed in the health center 
and transport settings where we anticipate the infant warmer will ultimately serve the greatest 
need. 
 
Confounders: Infant’s severity of illness, gestational age and weight, ambient temperature 
(relevant for infant warmer efficacy), bundling of infant, use of KMC, and distance from clinic 
to hospital (relevant for infant warmer use on transport). 
 
4. Selection of study population 
Inclusion, exclusion, and sampling procedures are the same as described above in Phase 1. They will 
simply occur in the health center setting during routine post-partum care, resuscitation/stabilization, and 
transport settings.  
 
4.1 Inclusion criteria: Any infant with the following criteria for whom caregiver not available for 
KMC, or KMC is not adequate (less than ½ degree Celsius per hour rise in temperature).  
1) axillary temperature < 36oC and ≥35oC 
1a) If an electric warmer is available and the infant’s temperature is < 35 oC, then the infant 
would start by being warmed on the electric warmer until the infant’s temperature reaches 36 
oC, then can start non-electric infant warmer use   
2) Infants at-risk for hypothermia (criteria: estimated post-menstrual age of < 35 weeks or 
current body weight of < 2.5 kg)  
3) Any infant requiring neonatal resuscitation or patient transfer. 
 
4.2 Exclusion Criteria:  
1) Any infant whose family is unwilling or unable (due to advanced stage of labor) to consent 
to study. 
2) Mothers who are critically ill at the time of infant eligibility or deemed not medically stable 
by nursing staff to be approached for consent.  
3) Any infant with initial temperature < 35oC and electrical heating source available. 
 
4.3 Stop Criteria:  
 
1) If an electric heating source is available, the infant will be taken off of the study and warmed 
with an appropriate source of electric heat if the infant: 
 
a) Is hypothermic and temperature decreases on any measurement 
 
b) Is hypothermic and temperature does not begin to rise within 30 minutes 
 
c) Is hypothermic and not heating at a rate of > ½ oC per hour until temperature is  
 
 
>36.5oC 
 
d) Has a temperature that falls below 36 oC despite maximum exposure to the heat source 
 
e) Is ever considered to be too severely ill by the medical team to be safely cared for in  
 
 
the non-electric infant warmer.  

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2) The warmer will be removed once its temperature drops below 36 degrees, and/or the   
 
phase change material begins to harden.  
 
4.4 Sampling: Continuous enrollment at PIH-supported district health centers as described in 
section 3.1.5.  
 
4.5 Recruitment Methods: Study managers will be present at the health centers to identify eligible 
patients in maternity. Once a patient has been identified as eligible, the study manager will 
approach the caregiver for consent. If consent is given, the study manager will then consent the 
treating nurse and inform him/her to begin preparing the infant warmer for use.   
 
4.6 Subject enrollment: All infants will be assigned a code by the order in which they are 
consented to participate. A password-protected file matching consent form code to 
identification code will be kept on a password-protected computer equipped with antivirus 
software. The identification code will be marked on the patient’s consent and data collection 
form.  The completed consent and data collection forms will be locked in a filing cabinet in a 
locked room. 
  
4.7 Randomization: None. 
 
5. Study Procedures 
Aim 1 study procedures are similar to those described in Phase 1, but assessed at the health center level 
during post-partum care, resuscitation/stabilization, and patient transport.  
 
5.1 Procedures at enrollment and Data Collection.  Since the infant warmer will be studied 
during neonatal resuscitation and transfer as well as routine post-partum care, potentially 
eligible mothers will be approached upon admission to the health center for possible enrollment 
in study. If consent is given, data collection will commence by a study manager if patient 
ultimately meets eligibility requirements.  
 
For usage during routine post-partum care and patient transport, thermoregulation protocol will 
be followed per routine. If the infant’s temperature with KMC alone does not rise by at least ½ 
degree per hour, addition of infant warmer will be offered. Whenever mother is unavailable for 
KMC, the infant will be placed on the infant warmer exclusively. Temperature measurement of 
the infant, warmer, and ambient air will be measured every 15 minutes for the first hour, and 
then hourly and as needed for the remainder of use or until warmer endpoint is reached (phase-
change material hardens or warmer temperature below 36 degrees). See also 3.1.5 for details of 
warmer positioning, role of electric heat source for study patients, and 4.2 for stop procedures 
for study.  
 
For usage during resuscitation, the temperature will be measured after initial stabilization (as 
would be on an electric warmer). No additional measurements will be taken that could interfere 
with patient resuscitation procedures.  
 
User audit for usability and functionality will be identical to Phase 1. 
 
5.2 Follow-up.  None 
 
5.3 Measurement of exposures, outcomes and confounders.  Exposure variable of KMC, usage 
setting, and infant warmer will be documented in data collection form (see Appendix E). 
Whenever the mode of thermoregulation and/or warmer position changes the change and time 

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of change will be documented on the data collection form. Data regarding potential 
confounders will also be collected on the data collection form.   
 
Infant’s temperature will be documented on a data collection form per protocol when used 
during routine post-partum care. Measurements will be immediately after infant stabilization if 
used during resuscitation, and hourly during patient transport.  Infant warmer temperature will 
be documented on a data collection form every hour during post-partum care and transport. The 
study manager will document at every application whether the infant warmer was prepared and 
used correctly with the infant. The study manager will document at the end of every infant 
encounter whether the warmer is properly cleaned and assessed for any visible signs of material 
breakdown or change. 
 
5.4 Study limitations: Limitations are as described in Phase 1.   
 
5.5 Lab measures: none 
 
5.6 Sample Size: As described in Phase I, we will use the calculations for sample size of 102.  We 
will conduct the study at four health centers to explore the potential variability of safety and 
efficacy across health centers. Because of feasibility issues, we aim to enroll a minimum of 25 
patients per health center to reach this total sample size. This assumes that there is no clustering 
of outcomes by health centers. Having enough health centers to account for potential clustering 
in our study design is not feasible at this stage. If clustering is high or if sample size is unable to 
be reached within 3 months per health center, then this data will be used to inform a larger 
study to better estimate the properties of the infant warmer.  
 
5.7 Data Management: Study supervisors will audit 10% of data transcribed from paper forms to 
an electronic Excel database to assure data quality (e.g., completeness and concordance 
between paper forms and electronic database). If the completeness and concordance is less than 
95% in the database, then the data from paper forms will be double-entered into the database. 
The completed consent and data collection forms will be locked in a filing cabinet in a locked 
room. 
 
5.8 Proposed analysis: Analysis for Aim 1 will be as described for Phase 1. 
 
Aim 2 
 
3. Methods 
 
3.1.1 Study description: Qualitative assessment of perceived usability, functionality and 
acceptability.  Because the infant warmers are intended for use at health care centers, it is 
important to use qualitative methods to understand the user experience with the warmers in 
greater depth than the quantitative data alone will provide. 
 
3.1.2 Study design:  Perceived usability, functionality and acceptability will be assessed through 
semi-structured interviews with infant caregivers who were present during use of the warmer 
(e.g. the mother or accompanying family member) and health care providers. The interviews 
will be tape-recorded. 
 
3.1.3 Study site: We will partner with PIH-IMB-supported health centers in Rwanda for the testing 
sites as described in Aim 1. 
 

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3.1.4 Study population: Health care providers; caregivers of infants exposed to infant warmer in 
the health care setting. 
 
3.1.5 Proposed Intervention: Use of infant warmer when KMC is contraindicated, not available or 
not adequate, as described in Aim 1.  
 
3.1.6. Main exposures, outcomes and confounders to be measured.  
 
Outcomes: Perceived usability, functionality and acceptability of the infant warmer will be 
assessed through semi-structured interviews with caregivers and health center nurses. 
 
4. Selection of study population 
 
4.1 Inclusion criteria: Any nurse or family member who has been involved in the care of an infant 
who has used the infant warmer for thermoregulation. 
 
4.2 Exclusion criteria: Caretaker of infants unwilling to consent to interview participation. 
Caregivers will not be approached for interview consent if the infant died during the encounter 
(for example, if the infant did not survive resuscitation or died during transport).  
 
4.3 Sampling: Caregivers of infants who received the warming intervention will be purposively 
selected to be invited to participate in interviews.  The purposive selection process will aim to 
maximize the diversity of the interviewees in terms of the following key characteristics 
expected to influence their experience with/perceptions of the infant warmer (see Appendix for 
the purposive sampling matrix tool that the Study Manager will use to keep track of the number 
of interviewees falling into each category):  
 
Mode of thermoregulation (including caregivers of infants who experienced IW 
alone, and infants who experienced IW plus KMC and, IW plus bundling) 
 
Setting of use (routine post-partum care, resuscitation, or transport).  
 
Observer audit results (including caregivers of infants where the observer recorded 
optimal application of the warmer, and infants where the observer recorded sub-
optimal application of the warmer) 
 
Among caregivers who consent to interview (see Ethical Considerations section for details on 
the recruitment and consent process), the interviews will be conducted until saturation has been 
reached: in other words, new interview participants will be sought until the interview responses 
are producing no new major themes or ideas.   
 
Additionally, 1-3 nurses will be interviewed per health center, prioritizing those nurses who 
have had the largest number of encounters with the warmer in the following settings: routine 
post-partum care, resuscitation, and transport (see Ethical Considerations section for details on 
recruitment and consent). 
 
4.4 Recruitment Methods: Study managers will approach for consent caregivers and health care 
providers who are eligible for the Aim 2 portion of the study on the basis of having participated 
in the Aim 1 portion of the study. They will be informed that they may participate in Aim 1 
without consenting to participate in Aim 2. If consent is given to participate in Aim 2, the study 
manager will arrange a time that is convenient for the participant to answer a series of interview 
questions. 
  
 4.5 Subject enrollment: All participants will be assigned a code by the order in which they are 
consented to participate. The code will be linked to the code of the infant whose participation in 

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Aim 1 prompted the caregivers and health care providers’ eligibility for Aim 2.  A password 
protected file matching consent form code to identification code will be kept on a password 
protected computer equipped with antivirus software. The identification code will be marked on 
the participants consent and data collection form.  The completed consent and data collection 
forms will be locked in a filing cabinet in a locked room. 
 
4.6 Randomization: None. 
 
5. Study Procedures 
 
5.1 Procedures at enrollment:  Nurses and family member who have been involved in the care of 
an infant who has used the infant warmer will be approached regarding willingness to 
participate in qualitative interviews as well as direct observation of infant warmer use. Nurses 
and family members will be formally consented to participate in study. While they will be 
consented for Aim 1 prior to use of the warmer, Aim 2 consent will happen prior to patient 
discharge for those using the warmer in routine post-partum care, or soon after stabilization or 
patient transport.  
 
Nurses, family members and caregivers will receive qualitative, semi-structured interviews in 
Kinyarwanda. Interview guides will be developed to assess perceived usability, functionality, 
and acceptability of the infant warmer (see Appendix for the interview guide for caregivers and 
the interview guide for nurses). 
 
5.2 Follow-up.  None 
 
5.3 Measurement of exposures and confounders.  None 
 
5.4 Measurement of outcome:  None 
 
 
5.5 Lab measures: none 
 
5.6 Sample Size: 10-15 caregivers and 1-3 nurses per health center. This is based on numbers 
typically needed in qualitative assessment before a theme is saturated. Goal will be to capture at 
least 3-5 encounters in each of the following settings: routine post-partum care, resuscitation, 
and transport. 
 
5.7 Data Management. Rwandan-based study manager to recruit patients, consent families, collect 
data, and conduct semi-structured interviews. The study manager will then translate and 
transcribe interviews into English for analysis prior to data analysis. An independent translator 
will back-translate 10% of interviews into Kinyarwanda and compare to original transcripts for 
validation.  
 
All caregivers and nurses participating in the qualitative interview will be assigned a code by 
the order in which they are consented to participate. A password-protected file matching 
consent form code to identification code will be kept on a password-protected computer 
equipped with antivirus software. The identification code will be marked on the patient’s 
consent and data collection form.  The completed consent and data collection forms will be 
locked in a filing cabinet in a locked room. Interviews are estimated to take 1 hour maximum. 
Destruction of audio recording will be the same as destruction of the linking file, 2 years after 
data collection. 
 

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5.8 Proposed analysis. Transcripts will be analyzed for emerging themes, and a codebook will be 
created to assist with data analysis 
 
PHASES 1 AND 2 
 
6. Ethical considerations 
 
6.1 Risks and discomforts: We did extensive safety, durability and performance testing as 
described in Appendices A & B; however, the potential for misuse by nurse providers remains. 
Therefore, we plan to do training for all providers in the use of the warmer and all study use 
will be supervised by the study staff.  
 
There is a minor risk of skin irritation due to contact with infant warmer. There is theoretically 
a risk of burn due to excessive heat exposure if an infant were to be placed on the warmer 
before the color indicator showed temperature to be < 40 degrees.  However, a primary purpose 
of the infant warmer is to avoid the burns that can occur with the currently practiced (though 
not officially endorsed) option of placing heated water bottles in direct contact with the infants’ 
skin: thus, the anticipated risks from the study are not expected to be greater, and may be less 
than the current standards. Additionally, the risk of burning or skin irritation will be mitigated 
by the presence of study staff during the use of the warmer, who will be instructed to intervene 
if a nurse attempts to place an infant on a warmer that is too hot.  
 
 
For patients enrolled with hypothermia and/or failure of KMC alone, another risk could be 
potential delay of warming if an electrical warmer is deferred in favor of study participation. 
However, per study protocol, patients will be placed on an electric warmer while the non-
electric warmer is being prepared so as not to delay thermoregulation. Furthermore, if the 
warmer is prepared ahead of time, the infant will be monitored every 15 minutes to allow for 
early detection of thermoregulation failure and transfer to electric warmer if appropriate. Given 
our inclusion criteria of stable infants appropriate for KMC (particularly for Phase 1), we 
believe this potential 15-minute delay is within the bounds of ethical and safe practice. In Phase 
2 the warmer will be introduced to the resuscitation setting (with potentially unstable term and 
preterm infants), which we believe to be appropriate with informed consent even in the setting 
of an electric warmer after demonstrating safety and efficacy in Phase 1.  
 
A third risk is breach of confidentiality for data collected that includes identifying information. 
Any health records that include patient level identification will be stored in a secure database if 
electronic or in a locked secure cabinet if not. Transcripts will be wiped of identifying 
information and instead marked with identification codes. Computers containing study data will 
be password protected and installed with anti-virus software, and all filing cabinets will be kept 
in locked offices. Any information will be de-identified before any reports or manuscripts are 
issued. All staff handling data will receive training in confidentiality and data security. Any 
gaps in security identified during the study will be communicated immediately to the principal 
investigators.  
 
6.2 Potential benefits: The infant could potentially benefit from participating in this study by 
having more normal and stable thermoregulation. This would have multiple health advantages 
regarding cardiorespiratory function, growth and nutrition.  
 
6.3 Confidentiality:  Patient confidentiality will be protected in the manners described above in 
section 6.1.  
 

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6.4 Informed consent: Informed consent will be obtained from all nurses and caregivers 
participating in Phase 1 or 2. A small incentive of 5000 RWF airtime will be offered to nurses 
who participate in the study as appreciation for the extra work done related to the study, 
particularly in preparation and application of the infant warmer. An incentive will also be given 
to caregivers and nurses who participate in the qualitative assessment (Phase 2, Aim 2) as an 
appreciation for their time (2000 RWF airtime). 
 
6.5 Ethical approval: Ethical approval will be obtained from the Rwanda National Ethics 
Committee and Boston Children's Hospital (BCH). Approval will also be sought from Harvard 
Medical School (HMS), either through ceded review to BCH or directly if the institution will 
not cede review. Technical approval has been received by the IMB Research Committee and 
National Health Research Committee.  
 
7. Logistics 
 
7.1 Distribution of responsibilities 
Evrard Nahimana MD: Field-based input on study design, determination of study design, data 
collection oversight, data analysis and interpretation, manuscript preparation. Partners in 
Health, 10% time. 
 
Hema Magge MD: Field-based input on study design, determination of study design, data 
collection oversight, data analysis and interpretation, manuscript preparation. Partners in 
Health, Boston Children’s Hospital, Brigham and Women’s Hospital, 10% time. 
 
Leana May DO: Field-based input on study design, determination of study design, data 
collection oversight, data analysis and interpretation, manuscript preparation. Partners In 
Health, 15% time. 
 
Anne Hansen MD: Technical input on product design, determination of study design, data 
interpretation, and manuscript preparation. Boston Children’s Hospital, 5% time. 
 
Bethany Hedt-Gauthier PhD: Determination of study design, data analysis and interpretation, 
manuscript preparation. National University of Rwanda School of Public Health, Harvard 
Medical School, 2.5% time. 
 
Annie Michaelis (PhD): Determination of study design, data analysis, interpretation and 
manuscript preparation for Phase II Aim 2 (qualitative study). Partners in Health, 2.5% time. 
 
Shashi Buluswar PhD: Product development and design, data interpretation. Institute for 
Transformative Technologies (ITT), 2.5% time. 
 
Victor Mivumbi, MD: Field-based input on product development, data interpretation and 
manuscript preparation. Rwanda Ministry of Health, 2.5% time. 
 
Peter Drobac MD: Study design, data interpretation and manuscript preparation. Partners in 
Health, Brigham and Women’s Hospital, 2.5% time. 
 
Fidele Ngabo MD: MOH study supervisor, field-based input on product development, study 
design, data interpretation and manuscript preparation. Rwanda Ministry of Health, 2.5% time. 
 
Rwandan-based study manager: Study oversight, patient recruitment and consent, data 
collection, user audits, qualitative data collection.  

RNEC Application 
Page 23 
 
 
7.2 Timetable: November 2014- Fall 2016 
Goal: November 2014– Fall 2015: The study has been approved by the Partners In Health 
Research Committee. When the prototype has been approved by the Ministry of Health and 
Bureau of Standards and the study has been approved by NHRC, RNEC, Harvard Medical 
School and Boston Children’s Hospital, with approval from the district hospital directors, 
we will start enrollment in Phase 1. Will continue enrollment until sample size achieved.  
Anticipate enrolling patients in Phase 1 for approximately 3 months per district.  
 
Goal: January 2016- July 2016: When data from phase 1 has been collected and analyzed, if 
infant warmer is determined to be a safe, efficacious, usable and functional alternative or 
addition to KMC, the data will then be shared with RNEC for approval of Phase 2. Infant 
warmers, with training to health centers, will be provided to begin Phase 2 safety/efficacy 
and feasibility (usability, functionality and acceptability) study. Phase 2 will take 
approximately 3 months per health center depending on volume seen and feasibility of 
study manager staying on-site continuously versus daily visits. Total time anticipated is 3-6 
months per district. 
 
Goal Fall 2016: Publish results of both phases and consider next steps regarding manufacturing 
and plan for scale and distribution.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

RNEC Application 
Page 24 
 
Appendix A: Infant Warming Blanket Durability, Performance and Safety Testing 
 
Component technical specifications, safety information, and certifications/approvals  
The warming mat has an external cover made of nylon (with the brand name PolyNylon), made by the 
company ULine (of Wisconsin, USA). It is certified compliant with both FDA and USDA. It is a strong 
material designed to hold air, fluids or vacuum, and withstand very high temperatures. It is easily heat-
sealed, and the seals are designed to withstand significant weight and pressure. The warming pad has two 
layers of ULine PolyNylon. The inner layer is in the form of tubes filled with the 37oC phase-change 
material (PCM). The PCM, made under the brand name PureTemp 37 by Entropy Solutions (of 
Minnesota, USA) is a mix of USDA-certified vegetable oils. It has been tested on animals and found to be 
non-hazardous, with the animal tests showing no eye or skin irritation. Being a vegetable-based product, it 
is also readily biodegradable. It is also certified to be safe for transport. It has been tested to stabilize at 
37oC for 10,000 cycles, with a maximum stabilizing temperature of 38.1oC. However, the manufacturer 
recommends against consumption, eye contact and prolonged exposure, and provides instructions for 
handling and medical attention if necessary.  The Appendix contains technical and safety data sheets for 
PureTemp 37, and a certificate of USDA/FDA compliance for ULine-PolyNylon. 
The temperate indicator is inserted between the inner and outer PolyNylon layers. It is made by TipTemp 
Products (of New Jersey, USA), and is made with another phase-change material. This material is non-
toxic, and does not come into contact with either the user or the infant because it is inside the outer 
PolyNylon layer. Exposure to very high temperatures (above 120oC, which can happen if water is boiled 
in a pressure cooker) is known to damage the material and adversely affect its accuracy; extended 
exposure to direct sunlight and UV can also damage the material and impact accuracy.   
The flask is a standard off-the-shelf product made by Coleman (USA) and is normally used for storing 
food, with one modification: we have inserted a custom-built lining made with an inert plastic in order to 
change the flask’s dimensions to fit our purpose.  
The insulating pad is made with two materials, both of which are non-toxic. The outer layer 
(manufactured by Coastal Films (of Florida, USA) is made of a linear low-density product (LLDPE) 
which is certified by both USDA and FDA. The inner foam pad, made with a non-toxic material 
(EVA/PE foam), has been manufactured by DerTex Corporation (of Maine, USA). The relevant 
certifications are attached in the Appendix. 
 
Product thermal performance and durability tests conducted  
In addition to the above certifications of the various components for toxicity, irritation and skin 
sensitization, the following performance and durability tests were successfully conducted on the product 
as a whole.  
 
Thermal performance 
The Thermal Performance tests were conducted in order to determine how long the mat retains its heat, 
and how long it can keep the infant warm.  Three tests were conducted, each measuring how long the mat 
stayed between 35oC and 38oC. In each case, the heated pad was placed on a Styrofoam board, in an 
environmental chamber simulating room temperature (about 22oC) 
1. No insulation: This test measures the time the mat retains the 35oC and 38oC temperature range, 
with nothing placed on it. A minimum threshold of 30 minutes was used to determine if this test 
had been successful. 
2. Estimated use: This test simulates conditions of the pad in use, with a surrogate infant (1.5 kg 
water bags that were heated to approximately 37oC in an oven before testing), small (3.8 W) light 
bulbs to simulate an infant’s metabolism, and two light cotton towels (to simulate the weight of a 
light blanket commonly used in hospitals). A minimum threshold of 120 minutes (2 hours) was 

RNEC Application 
Page 25 
 
used to determine if this test had been successful. Please note that the expected use of the mat is 
6-8 hours or longer, even though a minimum threshold of 2 hours was used for this test. 
3. Maximum insulation: This test determines the maximum time the pad retains the target 35oC-38oC 
temperature range, with a heated 1.5 kg water bag as a surrogate infant, and levels of insulation 
comparable to other products on the market. A minimum threshold of 180 minutes (3 hours) was 
used to determine if this test had been successful. Please note that under these conditions, the mat 
consistently retained the desired temperature range for more than 12 hours, even though the 
minimum threshold for this test is 3 hours. 
Performance testing: Summary 
Test type 
Criteria for 
passing the 
test 
Result  
No insulation  
30 minutes  
Pass 
Estimated Use 
120 minutes  
Pass 
Maximum insulation 
180 minutes  
Pass 
 
Durability  
Durability tests were conducted on candles consisting of 4x26 cm rectangles of the material filled with 
PCM. After 10, 30, 50, 70, and 100 cycles of each test, the candles were placed in a jar with boiling 
water. The water was observed for evidence of PCM in the water. If PCM crystals were observed, it was 
deemed that the material had failed. The approximate number of cycles before failure were recorded. If 
the material did not fail after 100 cycles, it was deemed to be a durable material for that specific test. 
1. Bend test:  For liquid PCM, half of a candle was held over the lab bench while a 200g weight was 
attached to the end furthest away from the bench. The weighted end was then let go and allowed 
to hang for 30 seconds. This was defined as one cycle. For solid PCM, the candle was marked 
halfway and placed over a marker on a lab bench at the mark. The two ends of the candle were 
pushed downward toward the lab bench at the same time until both ends touch the lab bench. This 
caused the candles to crack, and was defined as 10 cycles. 
2. Functional test: A 1kg weight was placed on top of the center of the candle for 5 min. This is 
equivalent to 1cycle. The weight was usually left for 10 cycles at a time (50 min). Often, the 
weight could not balance on the candle so it was tilted on a wall for additional support. 
3. Horizontal drop test: The candle was dropped horizontally onto a smooth floor from roughly 
1.5m above the ground. One drop was defined as 1 cycle. 
4. Vertical drop test: The candle was dropped vertically onto a smooth floor from roughly 1.5m 
above the ground. One drop was defined as 1 cycle. 
5. Rapid cooling test: The candle was placed in ice water for 15 minutes. The solid candle was 
originally at ambient temperature while the liquid candle was taken directly out of the hot water. 
Fifteen minutes of ice water exposure was defined as 1 cycle. 
6. Bleach test: Two different bleach exposure tests were performed—one with a diluted bleach 
solution and one with pure bleach. The diluted bleach solution consisted of 3 cups of water mixed 
with 22mL of Clorox bleach (the standard recommended use by Clorox for disinfection). The 
pure bleach solution consisted of 1 cup of pure bleach. Candles were left to soak in the solution 
for approximately 24 hours. 
 
 
 

RNEC Application 
Page 26 
 
Durability Testing: Summary 
Test type 
Criteria for passing the 
test 
Result  
Bend Test 
30 cycles, no leak 
Pass 
Functional Test 
30 cycles, no leak 
Pass 
Horizontal Drop Test   
30 cycles, no leak 
Pass 
Vertical Drop Test   
30 cycles, no leak 
Pass 
Rapid Cooling Test 
30 cycles, no leak 
Pass 
Bleach Pure 
No leak after 24 hours 
Pass 
Bleach Dilute  
No leak after 24 hours 
Pass 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

RNEC Application 
Page 27 
 
Appendix B: Infant Warmer Set-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Infant warmer: components 
3. Robust, 
insulated, leak-
proof flask  
4. Insulating pad 
(blue), to prevent 
heat loss and 
maximize warmth 
time 
1. The warming mat, 
which is an assembly 
of nylon pouches filled 
with a precise mixture 
of vegetable oils, 
which maintains the 
temperature at about 
37oC. It provides heat 
in the range of 
usability (35-38oC) for 
several hours 
5. Instruction sheet 
2. Temperature indicator (green with 
check mark) which shows when the 
mat is ready for use (between 35oC 
and 38oC)  

RNEC Application 
Page 28 
 
Appendix C: Budgets 
Study funding Source: Rosenfeld Fund from Harvard Medical School 
Phase 1 Budget: 
Activity 
Unit Cost 
Unit 
Number 
Total cost 
(USD=630 
RWF) 
Comment 
RNEC application 
1600 
1 
1600 
 
Yearly renewal 
800 
1 
800 
 
NHRC application 
300 
1 
300 
 
Staff 
 
 
 
 
Study Manager (1 per 
district) salaries 
600USD/month 
6 
3600 
Salary: 
600USD/month/for 
3months/2people 
Nurse incentives  
5000 RWF/month 
60 
500 
Approximate 10 nurses 
involved per district 
per month x 3 months 
Accommodations 
100 
6 
600 
1 study manager per 
district x 3 months 
each 
Data collection 
tablet/laptop 
800 
2 
1600 
For study manager  
laptop case 
50 
2 
100 
 
external hard drive 
100 
2 
200 
 
washing materials  
100 
1 
100 
Towels, soap 
electric kettle  
40 
2 
80 
 
Communication 
30 
6 
180 
Phone credits per study 
manager, 
30USD/month 
electronic thermometers 
10 
10 
100 
 
training for study 
managers 
100 
1 
100 
 
Orientation meeting for 
nurses 
50 
2 
100 
 
Translation  
500 
1 
500 
back-translation, parent 
guides, consent, 
information sheets etc 
Printing/binding  
100 
1 
100 
consent forms and 
other forms 
Data analysis  
190 
1 
190 
programming software 
TOTAL COST PHASE 1 
 
 
10750 
 
 
 
 
 
 
 
 

RNEC Application 
Page 29 
 
Phase 2 Budget: 
Activity 
Unit Cost 
Unit 
Number 
Total 
cost 
(USD) 
Comment 
Staff 
Study Manager 
salaries (1 per district) 
600USD/month 
12 
7200 
Remuneration for study managers: 
600USD/month/6months/2people 
Accommodation and 
transport for study 
managers at the health 
center 
100USD/month 
12 
1200 
 
Data Collection 
Communication for 
study managers 
50USD/month 
12 
600 
 
Nurse incentives (Aim 
1) 
5000 
RWF/month 
120 
950 
 
Incentive for 
qualitative 
participation 
2000 RWF 
72 
250 
15 caregivers and 3 nurses per 4 
health centers 
electric kettle 
40 
4 
160 
 
Info meeting for HC 
team 
50 
4 
200 
On-site meetings 
electronic 
thermometers 
10 
8 
80 
 
Printing/binding  
150 
1 
150 
consent forms and data collection 
forms 
Data analysis 
150  
1 
150 
qualitative software 
TOTAL COST PHASE 2 
 
 
 10940 
 
STUDY GRAND TOTAL 
 
 
21690 
 
 
 
 

RNEC Application 
Page 30 
 
Appendix D: Caregiver Consent Form for Warmer Use (Phases 1 and 2) 
 
INSHUTI MU BUZIMA 
PARTNERS IN HEALTH RWANDA 
Electricity-free Infant Warmer for Newborn Thermoregulation 
 
Consent Form 
Instructions: To be read aloud to the participant 
 
We are conducting a research study to understand the effectiveness of an infant warmer that does not 
require electricity as a strategy to improve care for newborns in Rwanda by keeping babies warm. The 
information we gather through this study will help us understand if and how this infant warmer can help 
prevent illness and death of newborns in Rwanda. 
 
If you and your treating nurse agree to participate in this study agree to participate in this study, the Study 
Manager will supervise the nurse preparing the infant warmer and ensure that it is properly and safely 
used on your baby to prevent or treat being cold. It should not interfere with skin-to skin warming and is 
intended as an alternative if you are not present or if skin-to-skin is insufficient. In hospitals, it may be 
used during routine care. In health centers, it may also be used in the case of resuscitation or transport. If 
it is not keeping your baby warm enough, we will move you to an electric warmer, if an electric warmer is 
available. Your baby’s health and safety is the number one priority. You can choose to stop use of the 
infant warmer at any time. Your baby’s temperature will be monitored frequently to make sure the baby is 
safely warm. You and your baby’s information will be kept confidential, which means we will never tell 
anyone outside of the study your name, age, or the village where you live. All data collection forms will 
be kept in a locked file. Only the members of our study team will have access to them. At the end of the 
assessment, these forms will all be destroyed. You are asked to participate for the length of your child’s 
hospital stay, which means that the infant warmer could be used on your child multiple times, but you 
may stop participation at any time with no negative consequences to you or your child’s care. 
 
If you choose not to participate in this study, there will be no negative consequences to your care in the 
hospital or health center. You will be treated just as if the  non-electric infant warmer did not exist and 
use skin-to-skin or an electric warmer to keep your baby warm. Your doctors and nurses will not treat you 
any differently. 
 
There is a small risk that your baby might experience skin irritation if the infant warmer is used when it is 
too hot, or that your baby may be warmed more slowly if the warmer is too cold. To keep this risk very 
low, the Study Manager will closely supervise the nurses using the infant warmer and will stop them from 
putting the baby into the infant warmer if it is not the right temperature and will monitor the baby’s 
temperature very closely to keep your baby healthy. There is also a risk of your private study information 
being shared. To prevent this, your personal information will be kept in a locked cabinet that only the 
study manager and primary investigators can locate, and will be destroyed 2 years after the end of the 
study.  
 
Benefits of the study could be closer temperature monitoring for your baby.  It is also possible that the 
infant warmer will keep your baby’s temperature more normal and stable than other options for warming. 
If you participate in the study, you will also help us to learn if this blanket is a good way to prevent cold 
temperature in newborns in Rwanda.  
 
If you have any questions about the study you can contact one of the following persons: 
1) Dr Evrard Nahimana, Study Manager, 07 88 89 77 34 or enahiman@pih.org 

RNEC Application 
Page 31 
 
2) Ancille Musabende, Pediatric Program Coordinator, 07 88 42 27 94 or amusabende@pih.orgIf there are any 
questions related to participant rights, please contact the Rwandan National Ethics Committee chair, Dr. 
Jean-Baptiste Mazarati 0788309807 or secretary Dr. Laetitia Nyirazinyoye 0738683209. 
 
 
Do you have any questions? 
Do you agree to be in this study? 
 
 
Yes (PROCEED) No (STOP) 
 
 
_____________________________________________                 
_________________ 
Caregiver Signature/Mark 
 
  
 
 
  
Date 
 
I attest that as a witness I was present throughout the entire consent process. The mother/father voluntary 
consents to participate in the above research statement.  
 
______________________________________________ 
 
___________________ 
Witness Signature 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INSHUTI MU BUZIMA 

RNEC Application 
Page 32 
 
PARTNERS IN HEALTH RWANDA 
Uburyo bwo kongerera ubushyuhe umwana ukivuka hadakoreshejwe amashanyarazi 
 
Urupapuro rutanga uburenganzira bwo kubazwa 
Amabwiriza: Bigomba gusomerwa ubazwa mu Kinyarwanda kandi mu ijwi ryigiye ejuru 
 
Turimo gukora ubushakashatsi bugamije kumva no gusobanukirwa uburyo buboneye bwo kongerera 
ubushyuhe abana bakivuka budasaba gukoresha amashanyarazi nk’ingamba yo kunoza imivurire y’abana 
bakivuka mu Rwanda dufureba impinja.  Amakuru tuzakusanya muri ubu bushakashatsi burebana no 
gukoresha uburyo bwo kongerera ubushyuhe umwana ukivuka azafashe mu kumva ndetse no 
gusobanukirwa uko iki kiringiti cyafasha mu kurinda indwara ndetse n’imfu z’abana bakivuka mu 
Rwanda. 
 
Niba wowe hamwe n’umuforomo ukuvura mwemeye kwitabira ubu ubushakashatsi, umuyobozi w’ ubu 
bushakashatsi azagenzura ko umuforomo ategura neza ikiringiti cyongerera ubushyuhe kandi ko 
anagikoresha mu buryo buboneye ku mwana wawe kugira ngo kimurinde ubukonje cyangwa se kimuvure 
gukonja. Ubu buryo bw’ikiringiti ntibugomba kubangamira uburyo busanzwe bwo gushyushya umwana 
umushyira mu gituza, ahubwo bwashyiriweho nk’ubwa kwifashishwa mu gihe umubyeyi adahari 
cyangwa mu gihe byaragaragaye ko uburyo bwo gushyushya umwana mu gituza budahagije. Mu bitaro 
ubu buryo bushobora gukoreshwa mu bikorwa by’ubuvuzi bya buri munsi. Mu bigo nderabuzima, ubu 
buryo bushobora gukoreshwa mu gihe bari kongerera amahirwe yo kubaho (kuzanzamura) umwana 
cyangwa se mu gihe bamutwaye ku bitaro. Mu gihe bigaragaye ko icyo kiringiti kitarimo guha ubushyuhe 
buhagije umwana wawe, tuzamwimurira kuri rya tara ritanga ubushyuhe rikoreshwa n’amashanyarazi 
niba hari irihari. Ubuzima ndetse n’ubusugire by’umwana wawe nibyo bishyirwa imbere kandi bihabwa 
agaciro. Ufite uburenganzira bwo guhitamo igihe icyo aricyo cyose guhagarika gukoresha ikiringiti 
cyongerera ubushyuhe umwana ukivuka. Ibipimo by’ubushyuhe bw’umubiri by’umwana wawe 
bizagenzurwa buri saha kugira ngo hakurikiranwe ku buryo bwizewe ko umwana wawe afite ibipimo 
by’ubushyuhe biboneye. Amakuru arebana nawe ndetse n’amakuru yose arebana n’umwana wawe 
bizagirwa ibanga, bisobanuye ko nta muntu tuzabwira amazina yawe cyangwa imyaka yawe ndetse 
n’izina ry’umudugudu utuyemo. Amakuru yose azakusanywa kuri iyi fishi azabikwa ahantu habugenewe 
hafungwa neza. Abantu bemerewe kugera kuri ayo makuru ni abakozi bo muri ubu bushakashatsi. 
Nibamara gukorera isuzuma sesengura ayo makuru, aya mafishi yose azatwikwa. Turagusaba kwitabira 
iki gikorwa cy’ubushakashatsi mu gihe cyose umwana wawe azamara arwariye muri ibi bitaro, bivuze ko 
ubu buryo bw’ikiringiti cyongerera ubushyuhe umwana ukivuka gishobora gukoreshwa ku mwana wawe 
inshuro nyinshi, ariko igihe icyo aricyo cyose ufite uburenganzira bwo kuba wahagarika ubwitabire 
bwawe muri ubu bushakashatsi ariko nta ngaruka bizakugiraho cyangwa se ku buvuzi buhabwa umwana 
wawe. 
Mu gihe uhisemo kutagira uruhare muri ubu bushakaashatsi, nta ngaruka mbi bizakugiraho ku birebana 
n’ubuvuzi uhabwa ku Bitaro no ku kigo nderabuzima. Bazakuvura nkaho buriya buryo bw’IKIRINGITI 
butigeze bubaho ahubwo bazakoresha uburyo busanzwe bwo gushyira umwana mu gituza ndetse no 
kumushyira ku itara ryagenewe kongerera umwana ubushyuhe. Abaganga n’abaforomo ntabwo 
bazagufata bitandukanye nuko bagufataga mbere y’ubu bushakashatsi. 
 
Gukoresha iki kiringiti cyongerera ubushyuhe abana bakivuka bishobora kugira ingaruka zidakomeye ku 
mwana wawe harimo ko gishobora kumutera ibibazo by’uruhu kubera ko icyo kiringiti kiba gishyushye 
cyane. Cyangwa umwana wawe ashobora kongererwa ubushyuhe buhoro buhoro mu gihe icyo kiringiti 
gikonje cyane. Mu kugabanya ibibazo bishobora kuba kuri uwo mwana kubera gukoresha ubwo buringiti, 
ushinzwe ubu bushakashati azakurikiranira hafi abaforomo uko bakoresha icyo kiringiti ndetse 
ntazabemerera ko bashyira icyo kiringiti ku mwana mu gihe igipimo cy’ubushyuhe nyacyo gisabwa 
ndetse azakomeza kugenzura hafi igipimo cy’ubushyuhe bw’umubiri bw’umwana kugira ngo ubuzima 
bw’umwana wawe bubungwabungwe. Indi ngaruka ishobora gukomoka kuri ubu bushakashatsi nuko 
amakuru yawe bwite arebana nawe muri ubu bushakashatsi ashobora gusangirwa. Mu kwirinda ko haba 

RNEC Application 
Page 33 
 
izo ngaruka, amakuru yawe bwite muri ubu bushakashatsi azabikwa mu kabati gafungwa neza, 
Umuyobozi w’ubu bushakashatsi hamwe n’abashakashati bo ku rwego rwa kabiri nibo bazamenya aho 
ayo makuru ashyinguwe; izo mpapuro zibitseho ayo makuru zikaba zizatwikwa imyaka ibiri nyuma yaho 
ubwo bushakashatsi burangiriye. 
 
Inyungu yo muri ubu bushakashatsi ni kugenzura ku buryo bwa hafi ibipimo by’ubushyuhe bw’umubiri 
w’umwana wawe. Birashoboka ko ubu buryo bw’ikiringiti cyongerera ubushyuhe abana bakivuka 
bushobora gutuma ubushyuhe bw’umuburi bw’umwana wawe buguma ku gipimo gisanzwe mu gihe 
bitari gushoboka mu gihe hakoreshejwe ubundi buryo bwo gufureba no kwongerera ubushyuhe abana 
bakivuka. Mu gihe witabiriye ubu bushakashati, uzadufasha kumenya niba iki kiringiti ari uburyo bwiza 
bwafasha mu kurinda ikibazo cy’ubukonje mu bana bakivuka mu Rwanda. 
 
Ufite ikibazo cyangwa icyo ushaka gusobanuza kuri ubu bushakashatsi, wahamagara umwe muri bano 
bakozi b'umuryango inshuti Mu Buzima:  
1) Dr Evrard Nahimana, ukurikirana ubushakashatsi, 07 88 89 77 34 cyangwa email: enahiman@pih.org 
2) Musabende Ancille umuhuzabikorwa ushinzwe ubuzima bw'abana kuri telephone 07 88 42 27 
94 cyangwa email: amusabende@pih.org 
Niba hari ibi bibazo birebana n’uburenganzira bw’abitabiriye ubu bushakashatsi, mwahamagara 
Umuyobozi Mukuru w’ Ikigo Rwanda National Ethics Committee Dr Jean-Baptiste Mazarati 07 88 30 98 
07 cyangwa Umunyamabanga Dr. Laetitia Nyirazinyoye 07 38 68 32 09. 
 
 
Hari ibibazo waba ushaka kubaza?  
 
 
 
 
Mwaba mwemeye kugira uruhare muri ubu bushakashatsi? Yego (Komeza) Hoya ( Hagarara) 
 
 
  
 
 
_____________________________________________                 
_________________ 
 Umukono cyangwa igikimwe cy’umurwaza 
  
 
 
 Itariki 
 
 
Ndemeza nk’umugabo w’igikorwa ko nari mpari mu gikorwa cyose cyigamije gutanga uburenganzira 
bwo kubazwa. Nyina/Ise bemeye ku bushake kugira uruhare mu bushakashatsi bwavuzwe haruguru. 
 
_____________________________________________                 
_________________ 
Umukono w’umuforomo 
 
 
 
 
 
 
Itariki 
 
 
 
 
 
 
 
 
 
 
Appendix E: Nurse Consent Form for Warmer Use (Phases 1 and 2) 
 
INSHUTI MU BUZIMA 
PARTNERS IN HEALTH RWANDA 
Comment [HA1]: Make sure signature line has 
“nurse” not “caregiver” in Ikenyarwanda version 

RNEC Application 
Page 34 
 
Electricity-free Infant Warmer for Newborn Thermoregulation 
 
Consent Form 
Instructions: To be translated into ikinyarwanda and offered to read aloud to the participant.  
 
We are conducting a research study to understand the effectiveness of an infant warmer that does not 
require electricity as a strategy to improve care for newborns in Rwanda by keeping babies warm. The 
information we gather through this study will help us understand if and how this infant warmer can help 
prevent illness and death of newborns in Rwanda. 
 
If you agree to participate in this study, the Study Manager will supervise you in preparing the warming 
blanket for an eligible patient and ensure that it is properly and safely used on the baby. This consent will 
be valid for your participation in the duration of the study in your unit. It should not interfere with 
kangaroo mother care and is intended as an alternative if the caregiver is not present or if skin-to-skin is 
insufficient. In hospitals, it may be used during routine care. In health centers, it may also be used in the 
case of reanimation or transport. If it is not keeping the patient warm enough, we will move the baby to an 
electric warmer if available. The patient’s health and safety is the number one priority. You can choose to 
stop use of the warming blanket at any time. The patient’s temperature will be monitored every hour to 
make sure the baby is safely warm.  Your will be kept anonymous, which means we will never tell your 
name to anyone. Data collection forms will be kept in a locked file. Only the members of our study team 
will have access to them. At the end of the assessment, these forms will be destroyed.  
 
If you choose to participate in the study, you will be given 5000 RWF airtime per month, in order to 
facilitate your work and communication required by participation in this study. 
 
If you do not choose to participate in this study, or at any point, decide you no longer want to be apart of 
the study, there will be no negative consequences to you or your job position in the hospital or health 
center. Your supervisors will not punish you in any way. 
 
There are no direct benefits to you from participating in the study. You will be helping us to learn if this 
blanket can help prevent cold temperature in babies that can cause death in newborns in Rwanda and the 
rest of the world. There is a small risk that an infant placed in the warmer might experience skin irritation 
if it is used when it is too hot. To prevent this, your personal information will be kept in a locked cabinet 
that only the study manager and primary investigators can locate, and will be destroyed 2 years after the 
end of the study. 
 
If you have any questions about the study you can contact one of the following persons: 
1) Dr Evrard Nahimana, Study Manager, 07 88 89 77 34 or enahiman@pih.org 
2) Ancille Musabende, Pediatric Program Coordinator, 07 88 42 27 94 or amusabende@pih.org 
If there are any questions related to participants rights, please contact the Rwandan National Ethics 
Committee chair, Dr. Jean-Baptiste Mazarati 0788309807 or secretary Dr. Laetitia Nyirazinyoye 
0738683209. 
 
 
 
 
 
 
Do you have any questions? 
Do you agree to be in this study? 
 
Yes (PROCEED) No (STOP) 
 
 

RNEC Application 
Page 35 
 
_____________________________________________                 
_________________ 
Nurse Signature 
  
 
 
  
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INSHUTI MU BUZIMA 
PARTNERS IN HEALTH RWANDA 
Uburyo bwo kongerera ubushyuhe umwana ukivuka hadakoreshejwe amashanyarazi 

RNEC Application 
Page 36 
 
 
Urupapuro rutanga uburenganzira bwo kubazwa 
Amabwiriza: Bigomba gusomerwa ubazwa mu Kinyarwanda kandi mu ijwi ryigiye ejuru 
 
Turimo gukora ubushakashatsi bugamije kumva no gusobanukirwa uburyo bwo kongerera ubushyuhe 
abana bakivuka budasaba gukoresha amashanyarazi nk’ingamba yo kunoza imivurire y’abana bakivuka 
mu Rwanda dufureba impinja. Amakuru tuzakusanya muri ubu bushakashatsi burebana no gukoresha 
uburyo bwo kongerera ubushyuhe umwana ukivuka azadufasha mu kumva ndetse no gusobanukirwa uko 
iki kiringiti cyafasha mu kurinda indwara ndetse n’imfu z’abana bakivuka mu Rwanda. 
 
Niba wemeye kugira uruhare muri ubu bushakashatsi, Umuyobozi w’ ubu bushakashatsi azakugenzura 
urimo gutegurira umurwayi wujuje ibisabwa mu guhabwa ikiringiti cyongerera ubushyuhe abana 
bakivuka kugira ngo yizere neza ko gikoreshwa neza mu buryo butanga umutekano ku mwana. Ubu uru 
rupapuro rutanga uburenganzira bwo kubazwa buzakoreshwa ku birebana n’ubwitabire bwawe mu gihe 
cy’ubushakashatsi mu gashami ukoreramo. Ubu buryo bw’ikiringiti cyongerera ubushyuhe abana 
bakivuka ntibugomba kubangamira uburyo busanzwe bwo gushyushya umwana umushyira mu gituza ( 
uburyo bwa kangaroo), ahubwo bwashyiriweho nk’ubwa kwifashishwa mu gihe umubyeyi cyangwa 
umurwaza adahari cyangwa mu gihe byaragaragaye ko uburyo bwo gushyushya umwana mu gituza 
budahagije. Mu bitaro ubu buryo bushobora gukoreshwa mu bikorwa by’ubuvuzi bya buri munsi. Mu 
bigo nderabuzima, ubu buryo bushobora gukoreshwa mu gihe bari kongerera amahirwe yo kubaho 
(kuzanzamura) umwana cyangwa se mu gihe bamutwaye ku bitaro. Mu gihe bigaragaye ko icyo kiringiti 
kitarimo guha ubushyuhe buhagije umurwayi, tuzamurira umwana kuri rya tara ritanga ubushyuhe 
rikoreshwa n’amashanyarazi niba hari irihari. Ubuzima ndetse n’ubusugire by’umwana nibyo bishyirwa 
imbere kandi bihabwa agaciro. Ufite uburenganzira bwo guhitamo igihe icyo aricyo guhagarika 
gukoresha uburingiti bwongerera ubushyuhe umwana. Ibipimo by’ubushyuhe by’umubiri w’umurwayi 
bizagenzurwa buri saha kugira ngo hakurikiranwe ku buryo bwizewe ko umwana afite ibipimo 
by’ubushyuhe biboneye. Amakuru arebana nawe ndetse n’amakuru yose akwerekeye  azagirwa ibanga, 
bisobanuye ko nta muntu tuzabwira amazina yawe.  Amakuru yose azakusanywa kuri iyi  fishi azabikwa 
ahantu habugenewe hafungwa neza. Abantu bemerewe kugera kuri ayo makuru ni abakozi bo muri ubu 
bushakashatsi. Nibamara gukorera isuzuma ayo makuru, aya mafishi yose bazayatwika. 
 
Niba wemeye kugira uruhare muri ubu bushakashatsi, uzahabwa ikarita yo guhamagara buri kwezi ingana 
n’amafaranga 5000 mu rwego rwo kugira ngo bigufashe mu kazi kawe ndetse izanagufasha mu birebana 
n’itumanaho mu rwego rwo kwitabira ubu bushakashatsi. 
Mu gihe utemeye kwitabira muri ubu bushakashatsi, cyangwa se hari aho ugeze ukumva utagishatse 
gukomeza kugira uruhare muri ubu bushakashatsi, nta ngaruka mbi zizakugera mu birebana n’akazi kawe 
mu bitaro cyangwa mu kigo nderabuzima. Nta bihano umuyobozi wawe azakugenera. 
Nta nyungu yako kanya uzabona zikomoka mu kugira uruhare muri ubu bushakashatsi. Uzaba udufasha 
mu kumenya niba ubu buringiti bushobora kurinda ubukonje bushobora guhitana impinja zikivuka mu 
Rwanda ndetse no ku isi hose. Gukoresha iki kiringiti cyongerera ubushyuhe abana bakivuka bishobora 
kugira ingaruka zitaremereye ku mwana wawe harimo ko gishobora kumutera ibibazo by’uruhu kubera 
ko icyo kiringiti kiba gishyushye cyane. Kubyirinda, amakuru yawe azabikwa mu kabati gafungwa neza, 
umuyobozi w’ubu bushakashatsi ndetse n’abamwunganira bo ku rwego rwa kabiri nibo bonyine 
bashobora kumenya aho ayo makuru ashyinguye,ikindi nuko impapuro zibitseho ayo makuru zizatwikwa 
imyaka ibiri nyuma yuko ubu bushakashatsi bushojwe. 
 
Ufite ikibazo cyangwa icyo ushaka gusobanuza kuri ubu bushakashatsi, wahamagara umwe muri bano 
bakozi b'umuryango inshuti Mu Buzima:  
1) Dr Evrard Nahimana, ukurikirana ubushakashatsi, 07 88 89 77 34 cyangwa email: enahiman@pih.org 
2) Musabende Ancille umuhuzabikorwa ushinzwe ubuzima bw'abana kuri telephone 07 88 42 27 
94 cyangwa email: amusabende@pih.org 

RNEC Application 
Page 37 
 
Niba hari ibi bibazo birebana n’uburenganzira bw’abitabiriye ubu bushakashatsi, mwahamagara 
Umuyobozi Mukuru w’ Ikigo Rwanda National Ethics Committee Dr Jean-Baptiste Mazarati 07 88 30 98 
07 cyangwa Umunyamabanga Dr. Laetitia Nyirazinyoye 07 38 68 32 09. 
 
Haba hari ikibazo cyangwa ibisobanuzo ufite? 
Wemeye kwitabira ubu bushakashatsi 
 
 Yego (Komeza) Hoya ( Hagarara) 
 
 
 
_____________________________________________                 
_________________ 
 Umukono cyangwa igikimwe cy’umurwaza 
  
 
 
 Itariki 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix F: Qualitative Interview Consent Form for Nurses and Caregivers (Phase 2) 
INSHUTI MU BUZIMA 

RNEC Application 
Page 38 
 
PARTNERS IN HEALTH RWANDA 
Electricity-free Infant Warmer for Newborn Thermoregulation 
 
Consent Form 
Instructions: To be translated into ikinyarwanda and offered to read aloud to the participant.  
 
We are conducting a study in order to understand the experiences and opinions of caregivers and nurses 
who have participated in using the infant warming blanket. We plan to interview 10-15 caregivers & 1-3 
nurses per health center. Our goal is to create a safe, simple, inexpensive way to keep babies warm and 
decrease newborn illness and death in Rwanda. If you agree to participate in this part of our study, you 
will be asked a series of questions to help us understand your views regarding the blanket. Information 
gathered from this assessment will help us improve or modify the blanket in order to be most useful to 
newborn health.  
 
Your responses will not affect your access to services, your employment as a provider of services, or the 
employment or those who provide services to you. You are not required to participate. You get to choose 
whether or not you want to participate in this evaluation. If you decide to participate and find that some of 
the questions make you feel shy or uncomfortable, you do not have to answer them. You can also stop the 
interview at any time, without being punished in any way. 
 
Your information will be kept anonymous, which means we will never tell your name, age, or the village 
where you live to anyone. With your permission, the interview will be audio-recorded. Only the members 
of our study team will have access to them. At the end of the assessment, these tapes will all be destroyed. 
There is a risk of your private study information being shared. To prevent this, your personal information 
will be kept in a locked cabinet that only the study manager and primary investigators can locate, and will 
be destroyed 2 years after the end of the study.  If you do not wish to be tape-recorded, please inform the 
interviewer.
 
As a token of appreciation for your time, you will be given 2000 RWF airtime 
 
 If you have any questions about the study you can contact one of the following persons: 
1) Dr Evrard Nahimana, Study Manager, 07 88 89 77 34 or enahiman@pih.org 
2) Ancille Musabende, Pediatric Program Coordinator, 07 88 42 27 94 or amusabende@pih.org 
If there are any questions related to participants rights, please contact the Rwandan National Ethics 
Committee chair, Dr. Jean-Baptiste Mazarati 0788309807 or secretary Dr. Laetitia Nyirazinyoye 
0738683209. 
 
Do you have any questions? 
 
Do you agree to be in this study? 
 
Yes (PROCEED) No (STOP) 
 
 
_____________________________________________                 
_________________ 
Participant Signature/mark 
 
  
 
 
 
Date 
 
 
 
 
 
For Caregiver participation: 
I attest that as a witness I was present throughout the entire consent process. The mother/father voluntary 
consents to participate in the above research statement.  

RNEC Application 
Page 39 
 
 
______________________________________________ 
 
___________________ 
Witness Signature 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INSHUTI MU BUZIMA 
PARTNERS IN HEALTH RWANDA 
Uburyo bwo kongerera ubushyuhe umwana ukivuka hadakoreshejwe amashanyarazi 
 
Urupapuro rutanga uburenganzira bwo kubazwa 
Amabwiriza: Bigomba gusomerwa ubazwa mu Kinyarwanda kandi mu ijwi ryigiye ejuru 
 
Turimo gukora ubushakashatsi bugamije kumva no gusobanukirwa ubunararibonye ndetse n’ibitekerezo 
by’abarwaza ndetse n’abaforomo bitabiriye mu ikoreshwa ry’ikiringiti cyongerera ubushyuhe abana 
bakivuka. Turateganya kugirana ibiganiro hagati y’abarwaza 10 na cumi na batanu ndetse n’abaforomo 
hagati ya 1 na 3 kuri buri kigo nderabuzima. Icyo tugamije nu gushyiraho uburyo bwizewe kandi 
bworoshye ndetse budahenze bwo kongerera ubushyuhe/ gufureba abana bakivuka ndetse no kugabanya 
indwara ndetse n’impfu z’abana mu Rwanda. Mu gihe wemeye kugira uruhare muri iki cyiciro 
cy’ubushakashatsi, uzabazwa ibibazo bitandukanye bizadufasha kumva neza no gusobanukirwa 
ibitekerezo byawe ku birebana n’iki kiringiti. Amakuru yose azakusanywa muri ubu bushakashatsi 
azadufasha mu kunoza cyangwa guhindura iki kiringiti kugira ngo kirusheho gufasha mu kurengera 
ubuzima bw’abana bakivuka. 
 
Ibisubizo byawe nta ngaruka bizakugiraho ku birebana no guhabwa serivisi cyangwa se ku kazi kawe 
nk’umwe mubatanga izo serivises, cyangwa se nanone akazi k’abaguha izo serivisi. Ntabwo usabwe 

RNEC Application 
Page 40 
 
kugira uruhare muri ubu bushakashatsi. Ufite uburenganzira bwo guhitamo niba ushobora kwitabira iri 
suzuma sesengura cyangwa udashaka kugira uruhare muri iri suzuma sesengura. Mu gihe wiyemeje 
kwitabira iri suzuma ugasanga harimo ibibazo bituma wumva utamerewe neza cyangwa bigutera isoni, 
ubufite uburenganzira bwo kutabisubiza. Ufite uburenganzira kandi bwo guhagarika iki kiganiro igihe 
icyo aricyo cyose kandi nta ngaruka bizakugiraho. 
 
Amakuru yose uzatangariza azagirwa ibanga, bisobanuye ko tutazagira undi muntu dutangariza amazina, 
imyaka yawe, cyangwa izina ry’umudugudu utuyemo. Mubiduhereye uruhushya, ikiganiro tuzagirana 
cyazafatwa ku byuma bifata amajwi. Abazagera kuri ayo makuru ni abagize gusa itsinda 
ry’ubushakashatsi. Nyuma y’ubu bushakashatsi aya makaseti azatwikwa.  Hari n’impungenge yuko 
amakuru yawe bwite ashobora gusangirwa. Mu kwirinda ko ibyo byaba, amakuru yawe bwite akureba 
azabikrwa mu kabati gafunze neza aho umukuru w’ubu bushakashatsi ndetse n’abamwugirije bo ku 
rwego rwa mbere ari bonyine bashobora kumenya aho ayo makuru abitswe, mu gihe cy’imyaka ibiri 
nyuma y’ubwo bushakashatsi nibwo ayo makuru azatwikwa. 
Mu gihe waba utifuza ko ikiganiro tugirana gifatwa ku byuma bifata amajwi, bimenyeshe umuntu 
ushinzwe 
ibazwa 
muzaba 
mugiye 
kugirana 
icyo 
kiganiro.
 
Uzagenerwa agashimwe k’ikarita yo guhamagara ya telephone yi 2000 kuko waduhaye umwanya wawe 
 
Ufite ikibazo cyangwa icyo ushaka gusobanuza kuri ubu bushakashatsi, wahamagara umwe muri bano 
bakozi b'umuryango inshuti Mu Buzima:  
1) Dr Evrard Nahimana, ukurikirana ubushakashatsi, 07 88 89 77 34 cyangwa email: enahiman@pih.org 
2) Musabende Ancille umuhuzabikorwa ushinzwe ubuzima bw'abana kuri telephone 07 88 42 27 
94 cyangwa email: amusabende@pih.org 
Niba hari ibi bibazo birebana n’uburenganzira bw’abitabiriye ubu bushakashatsi, mwahamagara 
Umuyobozi Mukuru w’ Ikigo Rwanda National Ethics Committee Dr Jean-Baptiste Mazarati 07 88 30 98 
07 cyangwa Umunyamabanga Dr. Laetitia Nyirazinyoye 07 38 68 32 09. 
 
Hari ibibazo ufite cyangwa ibyo waba ushaka gusobanuza? 
Waba wemeye kwitabira ubu bushakashatsi? 
 yego (Komeza) Hoya (Hagarara) 
 
 
 
_____________________________________________                 
_________________ 
Umukono cyangwa igikumwe cy’uwitabiriye ikiganiro  
             Itarik 
 
 
 
Ndemeza nk’umugabo w’igikorwa ko nari mpari mu gikorwa cyose cyigamije gutanga uburenganzira 
bwo kubazwa. Nyina/Ise bemeye ku bushake kugira uruhare mu bushakashatsi bwavuzwe haruguru. 
 
_____________________________________________                 
_________________ 
Umukono w’umuforomo 
 
 
 
 
 
 
Itariki 

RNEC Application 
Page 41 
 
Appendix G: Infant Warmer Data Collection Form 
During Infant Warmer Use 
If at risk for hypothermia, follow thermoregulation per neonatal protocol. If temp < 36OC, start 
thermoregulation with Kangaroo Mother Care (KMC) unless contraindicated. 
 
Consider enrollment in Infant Warmer (IW) Study: 
 
Inclusion Criteria (check all that apply) 
 
 Temperature < 36OC 
 
 At risk for hypothermia 
 
 
  Estimated post menstrual age (PMA) < 35 weeks  
(PMA = gestational age + chronologic age. A 7 day old 33 week gestation baby has a 
 PMA of 34 weeks) 
 Current body weight < 2.5 kg 
Exclusion criteria:  
 Family unwilling to consent to study,  

Mother not medically stable enough to approach for consent, per nursing judgment.  
 
Consent obtained 
Consent denied  
 
Participant ID Phase 1 (1- 102): ___________  
Participant ID Phase 2 (1- 40 per health center): _________ 
Date of Birth: _____________ 
Today’s Date: _____________ 
Name of Hospital/Health Facility: _______________ 
Birth weight: __________________ 
Today’s weight: __________________ 
Gestational Age: __________________ 
 
Severity of Illness (check all that apply) 
Vital Sign instability 
(specify:______________________________________________________________________) 
Other__________________________________________________________________________ 
Setting of Use (check all that apply): 
Hospital care of hypothermic and/or LBW/preterm infant 
Routine post-partum care 
Reanimation  
Transport (e.g. from health center to hospital)  
 
Received electric heat source while infant warmer prepared and/or consent signed?  yes  no 
Taken off study because hypothermic and not warming > ½ OC/hour?     
 
yes  no 
Taken off study because unable to maintain temp > 36 OC despite max exposure?   yes  no 
Taken off study because determined to be too ill by medical team? 
 
   
yes   no 

RNEC Application 
Page 42 
 
Participant ID:                     Date:                                    TIME BASED DATA FLOW SHEET 
          
Temperature: 
Infant/Warmer/Air 
Position of color 
change indicator 
Mode of thermoregulation  
(check all that apply)    
Comments 
Start of study 
 
 
 
__ __ : __ __ 
 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 
 
IW
KMC  
blanket        bundling 
hat 
     
15 minutes 
 
 
 
__ __ : __ __ 
 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC  
blanket        bundling 
hat 
 
30 minutes 
 
 
 
__ __ : __ __ 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC  
blanket        bundling 
hat 
 
45 minutes 
 
 
 
__ __ : __ __ 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC  
blanket        bundling 
hat 
 
1 hour 
 
 
 
__ __ : __ __ 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC  
blanket        bundling 
hat 
 
2 hours 
 
 
 
__ __ : __ __ 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC blanket 
blanket        bundling 
hat  
 
3 hours 
 
 
 
__ __ : __ __ 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC  
blanket        bundling 
hat 
 
4 hours 
 
 
 
__ __ : __ __ 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC  
blanket        bundling 
hat 
 
5 hours 
 
 
 
__ __ : __ __ 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC  
blanket        bundling 
hat 
 
6 hours  
 
 
__ __ : __ __ 
           /             / 
Hot frowny face 
Warm smiley face 
Cold frowny face 

IW
KMC  
blanket        bundling 
hat 
 

RNEC Application 
Page 43 
 
Infant Warmer Data Collection Form 
Phase 1 study, Observer audit 
 
Participant ID:___________________ 
Infant Warmer ID:________________ 
Date:________________     Time: ________________ 
 
1. a) Time Decision made to prepare warmer: ___________ 
     
    b) Time warmer placed in boiling water: _____________ 
 
    c) Time warmer removed: _____________ 
 
    d) Time warmer safety color change indicator turns: ___________ 
 
    e) Time of application of warmer to patient: __________ 
 
2. Did health care worker attempt to place infant on warmer before it has cooled adequately 
(before color indicator demonstrated safe temperature)?  Yes     No    If yes, describe: 
______________________________________________________________________________
______________________________________________________________________________ 
 
3. Was infant positioned on warmer correctly?  Yes     No    If yes, describe: 
______________________________________________________________________________
______________________________________________________________________________ 
 
4. Was there any other deviation or attempted deviation from recommended infant warmer 
use?   Yes     No    If yes, describe: 
______________________________________________________________________________
______________________________________________________________________________ 
 
5. If the warmer was inappropriately used, did it cause an adverse event? (See SoP page 7 for 
adverse event reporting)  Yes     No    If yes, describe 
 
______________________________________________________________________________ 
 
6. Is there any evidence of skin irritation associated with use of the warmer?  Yes     No     
 
If yes, describe: 
______________________________________________________________________________
______________________________________________________________________________ 
 
 

RNEC Application 
Page 44 
 
Participant ID:___________________ 
Infant Warmer ID:________________ 
Date:________________     Time: ________________ 
 
7. Was warmer cleaned properly with 10% chlorhexidine or soap and water?:  Yes     No    
If issues with cleaning, describe: 
______________________________________________________________________________ 
 
 
Not thoroughly cleaned?  
Water not available  
Water available but not used? 
 
Soap not available   
Soap available but not used? 
  
 
Other Concerns/Comment_________________________________________________ 
 
8. Did warmer demonstrate any breakdown or other change?  Yes     No  If yes, describe: 
______________________________________________________________________________ 
______________________________________________________________________________ 
 
 
Other changes of warmer? Concern/Comment______________________________________ 
 
9. Any other comments, concerns of observations: 
______________________________________________________________________________
______________________________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

RNEC Application 
Page 45 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix I: Infant Warmer Data Collection Form 
Phase 2 Study 
Qualitative Interview Questionnaire: Caregivers of Infants 
 
Name of researcher: __________________________________      
Date of interview: ______________ 
Study code # for infant belonging to this caregiver: ________  
Health Center name: _________________________________ 
 
 
Introduction script:  
As you know, your baby experienced the use of a new kind of warming blanket to help keep newborn 
babies warm. We are trying to understand if this new infant warmer is helpful, or how it could be 
improved for the future.  As a caregiver of a baby who has used this new infant warmer, we are talking to 
you today to understand your opinions about the infant warmer.  This is an anonymous study; your 
identity will not be shared with anyone. Your opinions are important to us, so please say what you think.  
There are no wrong answers, and we are especially interested to hear about any challenges or problems 
with the infant warmer that you might have experienced.  I will be audio-recording our conversation, to 
make sure I remember everything that you say.  Do you have any questions for me before we start the 
interview?  
 
1) To start, I’m curious to hear how you would describe the infant warmer. What does it look like? 
 
Do you like the way it looks? Why/why not? 
 
Is the material soft? 
 
Does it seem like a safe thing to put a new baby onto? Why/why not? 
 
Did you have a chance to see the color indicator that shows whether the warmer is the right 
temperature? 
➢If yes, did you understand what the color indicator was for?   
➢Does it seem like something that helps nurses use the warmer correctly? 
 
2) Please tell me about your experience seeing the infant warmer used with your baby: what happened?  
 
When did the nurse first say that it was time to use the infant warmer? 
 
Was the warmer used before or after the baby had been placed skin-to skin with you to warm? 
 
Did you understand what the purpose of the infant warmer was? 
 
What was it like to see the infant being put on or inside the warmer? 
 
Did you have any fears or concerns about the warmer?  How so? 
 

RNEC Application 
Page 46 
 
3) Were there any difficulties with getting the infant positioned on the warmer?  
 
Did the nurse seem to have any trouble measuring the infant’s temperature while the baby was on 
the warmer? 
 
Did the warmer seem comfortable for the infant to be on? 
 
4) How do you think this infant warmer compares to other ways you may have seen new babies kept 
warm?  
 
Have you ever seen new babies kept warm in a way other than the infant warmer? 
 
Do you think the infant warmer is more helpful or less helpful, compared to other ways of 
keeping babies warm? 
 
Have you ever seen new babies kept warm on an electric warming table? 
 
If so, do you think the infant warmer is more helpful/safe or less helpful/safe than an electric 
warming table? 
 
5) Did you [or, for other caregivers: did the baby’s mother] have a chance to hold the baby close either 
before or after using the infant warmer? 
 
Were there any ways that it was difficult to have a normal interaction between you and baby 
because of the infant warmer? 
 
6) Overall, what is your opinion of the infant warmer? 
 
Would you want the infant warmer to be used on another new baby in your family, if the baby 
had a similar need for warming up? 
➢ Why/why not? 
 
Would you recommend to your friends that they should ask to use the infant warmer if their 
babies need warmth? 
➢Why/why not? 
 
7) Is there anything else you can tell me about your experience with the infant warmer before we finish 
our conversation? 
 
 
Thanks so much for participating in this interview! 
  
 
 
 
 
 
 
 
 
 
 
 

RNEC Application 
Page 47 
 
 
 
 
 
 
 
 
 
INSHUTI MU BUZIMA 
PARTNERS IN HEALTH RWANDA 
Uburyo bwo kongerera ubushyuhe umwana ukivuka hadakoreshejwe amashanyarazi 
 
 
Umugereka wa J: Ifishi yo kwandimo amakuru arebana n’ikoreshwa ry’uburyo bushya bw’ikiringiti 
cyongerera ubushyuhe abana bakivuka 
 
Icyiciro cya kabiri cy’ubushakashatsi 
 
Ibibazo bigamije gucukumbura ireme bigenewe ababyeyi cyangwa abarwaza b’abana bakivuka 
 
Amazina y’umushakashatsi: ___________________________       
Itariki ikiganiro cyabereyeho: _______________ 
Umubare w’ibanga wahawe uyu mwana w’uyu mubyeyi muri ubu bushakashatsi: ________  
Izina ry’ikigo nderabuzima: _________________________________ 
 
Iriburiro: 
 
Nkuko mubizi umwana wawe yagize uruhare mu bushakashatsi burebana no gukoresha uburyo bushya 
bw’ikiringiti cyongerera ubushyuhe abana bakivuka. Mu rwego rwo kumva no gusobanukirwa neza uko 
ubwo buryo bushya bw’ikiringiriti cyongerera ubushyuhe abana bakivuka bwagufashije, cyangwa se ni 
mu buhe buryo  bw’ikiringiti cyongerera ubushyuhe abana bakivuka bwarushwaho kunozwa ku buryo 
bwisumbuye mu gihe kizaza. Nk’umubyeyi cyangwa umurezi w’uyu mwana wakoresheje ubu buryo 
bushya bw’ikiringiti cyongerera  ubushyuhe umwana ukivuka. Uyu munsi twaje kuganira nawe kugira 
ngo twumve ndetse tunasobanukirwe ibyiyumviro byawe ku birebana n’ ubu buryo bushya bw’ ikiringiti 
cyongerera ubushyuhe abana bakivuka. Ubu bushakashatsi ntabwo buzagaragaza umwirondoro wawe; nta 
wundi muntu tuzagaragariza umwirondoro wawe. Ibitekerezo byawe n’ingenzi kuri twebwe, mwisanzure 
mutubwire icyo mutekereza. Nta bisubizo bitari byo ndetse dushishikajwe by’umwihariko kumva 
imbogamizi n’ibibazo ushobora kuba waragize mu gukoresha ubu buryo bushya bw’ ikiringiti cyongerera 
ubushyuhe abana bakivuka. Iki kiganiro turi bugirane ndagifata mu byuma bifata amajwi, ibi ni kugira 
ngo nzabashe kwibuka  ibyo twaganiriye byose. Hari ikibazo mwaba mufite mbere yuko dutangira iki 
kiganiro? 
 
1) Mu gutangira, mfite amatsiko yo kumva icyo watubwira mu buryo ranga shusho bw’ ubu buryo bushya 
bw’ikiringiti cyongerera ubushyuhe abana bakivuka? Ese iki kiringiti kigaragara gute? 
 
Ese waba ukunda uburyo iki kiringiti giteye? Kubera iki/ kubera iki atariko bimeze? 
 
Iki kiringiti cyaba cyoroshye? 
 
Ese byaba byoroshye gushira umwana kuri kino gikoresho? Kubera ik/ kubera iki atariko bimeze? 

RNEC Application 
Page 48 
 
 
Wigeze ugira amahirwe yo kubona ibara ry’ikimenyetso ndangagikorwa ryerekana ko ikiringiti 
kiri ku gipimo nyacyo cy’ubushyuhe ? 
➢ Niba ari yego, waba warasobanukiwe nicyo iryo bara ry’ikimenyetso ndangagikorwa 
risobanura?   
➢ Byaba byarakugaragariye nkaho ari ikintu gifasha abaforomo gukoresha neza ubu 
buryo bushya bw’ ikiringiti cyongerera ubushyuhe abana bakivuka? 
 
2) Mwatubwira uko wabonye ubu buryo bushya bw’ikiringiti cyongerera ubushyuhe abana bakivuka 
cyakoreshejwe ku mwana wawe: byagenze gute? 
 
 Niki umuforomo yakubwiye bwa mbere ubwo yakubwira ko hageze igihe cyo gukoresha 
ikiringiti cyongerera ubushyuhe abana bakivuka? 
 
Ese ubu buryo bushya bw’ikiringiti cyongerera ubushyuhe abana bakivuka bwaba 
bwarakoreshejwe mbere cyangwa nyuma yuko umwana yari yashyizwe mu gituza cya mama we 
kugira ngo ashyuhe? 
 
Waba warasobanukiwe n’ impamvu y’ikoreshwa ry’ubu buryo bushya bw’ ikiringiti cyongerera 
ubushyuhe abana bakivuka? 
 
Ese wabyakiriye ute ubonye uruhinja rwawe barushyize kuri ikiringiti cyongerera ubushyuhe 
abana bakivuka? 
 
Hari ubwoba cyangwa impungenge wagize ku birebana n’ubu buryo bushya bw’ikiringiti 
cyongerera ubushyuhe abana bakivuka? 
 
3) Hari ingorane wagize zo gushyira umwana neza kuri icyi kiringiti cyongerera ubushyuhe abana 
bakivuka?  
 
Hari ubwo umuforomo yagowe no gufata ibipimo by’ubushyuhe mu gihe umwana yari yashyizwe 
muri icyo kiringiti cyongerera ubushyuhe abana bakivuka? 
 
Wabonye ubu buryo bushya bw’ ikiringiti cyongerera ubushyuhe abana bakivuka giha 
umudendezo umwana bagishyizemo? 
 
4) Niki utekereza kuri ubu buryo bushya bw’ ikiringiti cyongerera ubushyuhe abana bakivuka 
ugereranyije n’ubundi buryo bukoreshwa mu kongerera ubushyuhe abana waba warabonye? 
 
Hari ubwo wigeze ubona aho impinja zifurebwa mu bundi buryo butari ubu buryo bushya 
bw’ikiringiti cyongerera ubuhushye abana bakivuka? 
 
Uratekereza ko ubu buryo bushya bw’ iki kiringiti cyongerera ubushyuhe abana bakivuka gifasha 
cyangwa ntago gifasha, ugereranyije n’ubundi buryo bukoreshwa mu kongerera ubushyuhe abana 
bakivuka? 
 
Waba warigeze ubona aho abana bakivuka bongererwa ubushyuhe hakoreshejwe itara rikoresha 
amashanyarazi ryongerera ubushyuhe  abana bakivuka? 
 
Niba waragize kubona aho ubundi buryo bukoreshwa, utekereza ko ubu buryo bushya 
bw’ikiringiti cyongerera ubushyuhe abana bakivuka bufasha/bwizewe cyangwa budafasha/kandi 
butizewe ugereranyije n’itara rikoresha amashanyarazi ryongerera ubushyuhe abana bakivuka? 
 
5) Waba [cyangwa abandi babyeyi]waragize amahirwe yo guterura umwana umwiyegerejeho mbere 
cyangwa nyuma yo gukoresha ubu buryo bushya bw’ikiringiti cyongerera ubushyuhe abana bakivuka? 
 
Haba hari igihe waba warabogamiwe mu guhuza urugwiro hagati y’umwana n’umubyeyi nkuko 
bisanzwe bitewe n’ubu buryo bushya bw’ikiringiti cyongerera ubushyuhe abana bakivuka? 
 
6) Muri rusange, niki wavuga ku birebana n’ubu buryo bushya bw’ikiringiti cyongerera ubushyuhe abana 
bakivuka? 
 
Wakwifuza ko ubu buryo bushya bw’iki kiringiti cyongerera ubushyuhe abana bakivuka ko 
cyakoreshwa ku wundi mwana ukivuka wo mu muryango wawe, mu gihe bigaragaye ko uwo 
mwana ukivuka akeneye kongererwa ubushyuhe? 
➢ yego kubera iki/ kubera iki ataribyo? 

RNEC Application 
Page 49 
 
 
Wumva washishikariza inshuti zawe ko zasaba ko ubu buryo bushya bw’ikiringiti cyongerera 
ubushyuhe abana bakivuka bwakoreshwa mu gihe abana babo bakenewe kongererwa ubushyuhe? 
➢ yego kubera iki/ kubera iki ataribyo? 
 
7) Haba hari ikindi kintu mwifuza kumbwira mbere  ku birebana n’ uburyo mwabonye iki kiringiti 
cyongerera ubushyuhe abana bakivuka mbere yuko dusoza iki kiganiro? 
 
Turagushimira kuba witabiriye iki kiganiro! 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix J: Infant Warmer Data Collection Form 
 
 
 
 
 
Phase 2 Study 
Qualitative Interview Questionnaire: Health Center Nurses 
 
Name of researcher: ___________________________       
Date of interview: _______________ 
Study code # for nurse: _________________________   
Health Center name: ___________________________ 
 
Introduction script:  
As you know, we are doing a trial of a new infant warmer, in order to understand how well it works, and 
how it is accepted by the people using it.  As a nurse who has helped with this study, we are talking to 
you today about your experiences with the infant warmer.  This is an anonymous study; your identity will 
not be shared with anyone. Your opinions are important to us, so please say what you think.  There are no 
wrong answers, and we are especially interested to hear about any challenges or problems with the infant 
warmer that you might have experienced.  I will be audio-recording our conversation, to make sure I 
remember everything that you say.  Do you have any questions for me before we start the interview? 
 
1) To start, I’m interested to hear what it was like for you to learn about how to use this new infant 
warmer? 
 
How do you remember when to put an infant on or take the infant off of the warmer? 
 
Was there anything that made it difficult to learn how to use the warmer properly? 
 
2) What do you think about the instructions on the warmer (show warmer instructions to participant)? 
 
Did you usually look at the instructions when you were using the warmer?  Why/why not? 
 
Are the instructions written in a way that they are easy to understand? 
 
Is there some way the instructions could be changed to make them more appropriate or easy to 
understand?  
 
3) How would you describe the ease or difficulty of heating up the infant warmer? 
 
Was it easy or difficult to obtain hot water in order to heat up the warmer? 
 
Once put in hot water, did it warm up quickly enough? 
 
4) What other methods have you used, or seen used to provide heat to a newborn who is cold, other than 
kangaroo mother care?  
 
How does heating the infant warmer compare to these other methods? 
 
Have you ever seen new babies kept warm on an electric warming table? 

RNEC Application 
Page 50 
 
 
If so, do you think the infant warmer is more helpful/safe or less helpful/safe than an electric 
warming table? 
 
5) How do you decide when it is safe to begin using the infant warmer? 
 
Is it easy or difficult to see changes in the color indicator? 
 
Was there ever a time when you weren’t sure the infant warmer was ready for use? 
➢If yes: please describe what happened 
 
6) How would you describe the ease or difficulty of putting the infant onto the warmer as instructed? 
 
Were there any challenges measuring the infant’s temperature while the infant was on the 
warmer? If so, please describe. 
 
7) How would you describe the ease or difficulty of cleaning the warmer?  
 
How much time does it take to clean the warmer? 
 
Where do you find clean water and soap in order to clean the warmer? 
 
8) The infant warmer was designed to be used in routine post-partum care, reanimation, and during 
transport. In which of these ways have you used the warmer?  
 
For each of the ways you have used the warmer: 
➢How did it work in this circumstance? 
➢Is there one setting in which it worked better than in others?  How so? 
 
9) If the infant warmer were to be used routinely at this health facility, how many warmers would you 
need in order to be prepared in time for all circumstances? 
 
Would you need one especially for emergencies? Non-emergencies? 
 
Would you need one especially for infants who must be transported to the hospital? 
 
What is the greatest number of women you have ever had delivering at the same time at this 
facility?  
 
10) Did you notice any material breakdown or other change in the way the warmer looks or works?  
 
Were there any scratches, burns, or other changes to the material of the warmer? 
 
Were there any changes in how the color indicator changes when it changes temperature? 
 
11) How would you describe the way the warmer looks and feels? 
 
Is it comfortable for the infants? 
 
Does it look like a safe thing to put an infant onto? 
 
How do mothers and family members react to the way the warmer looks and feels? 
 
12) In your experience, does it seem comfortable for mothers to use in addition to KMC? 
 
If no: what are the aspects of using the infant warmer that the mothers do not find comfortable? 
 
13) Does having the infant warmer change how often you recommend mothers to do KMC? 
 
Are there still circumstances when you recommend using only KMC and not the infant warmer? 
 
14) Are there any other ways you could think to improve the infant warmer? 
 
15) Is there anything else you can tell me about your experience with the infant warmer before we finish 
our conversation? 
 
 
Thanks so much for participating in this interview! 
 

RNEC Application 
Page 51 
 
 
 
 
 
 
 
 
 
 
 
 
 
INSHUTI MU BUZIMA 
PARTNERS IN HEALTH RWANDA 
 
Icyiciro cya kabiri cy’ubushakashatsi 
Ibibazo bigamije gucukumbura ireme bigenewe abaforomo (kazi) bo ku Bigo Nderabuzima 
 
Amazina y’umushakashatsi: ___________________________       
Itariki ikiganiro cyabereyeho: _______________ 
Nimero yagenewe umuforomo muri ubu bushakashatsi: _________________________   
 Izina ry’ikigo nderabuzima: ___________________________ 
 
Iriburiro:  
Nkuko mubizi, turimo turakora igeragezwa ku buryo bushya bugenewe kongerera ubushyuhe abana 
bakivuka; mu rwego rwo kumva no gusobanukirwa neza uko bikorwa ndetse nukumenya uko abakoresha 
ubwo buryo babwumva kandi banabwemera. Nk’umuforomo (kazi) wagize uruhare muri ubu 
bushakashatsi, uyu munsi twaje kuganira nawe ku birebana nuko wabonye ubwo buryo bwo kongerera 
ubushyuhe abana bakivuka. Muri ubu bushakashatsi amakuru utanga agirwa ibanga, amazina yawe nta 
wundi uzayamenya. Ibitekerezo byawe ni ingenzi kuri twebwe, muvuge icyo mubitekerezaho. Nta 
bisubizo bitari byo, ndetse dushishikajwe cyane no kumva imbogamizi cyangwa ibibazo bikomoka kuri 
ubu buryo bwo kongerera ubushyuhe abana bakivuka mwaba mwarahuye nabyo. Iki kiganiro tugirana 
ndagifata mu byuma bifata amajwi kugira ngo nzabashe kwibuka ibyo twaganiriye byose. Hari ikibazo 
cyangwa icyo mushaka gusobanuza mbere yuko dutangira iki kiganiro? 
 
1) Mu gutangira, nshishikajwe cyane no kumva uko wakiriye gukoresha ubu buryo bushya bwongerera 
abana bakivuka ubushyuhe? 
 
Waba wibuka igihe ugomba gushyira umwana ukivuka mu kiringiti cyimwongerera ubushyuhe 
cyangwa se kukimukuramo? 
 
Haba hari ikintu cyaba cyarakubereye imbogamizi mu buryo bwo kwiga uko bakoresha neza iki 
kiringiti cyongerera ubushyuhe abana bakivuka? 
 
2) Niki utekereza ku birebana n’amabwiriza yo gukoresha ubu buryo bw’ikiringiti kongerera ubushyuhe 
abana bakivuka? (Ereka uwitabiriye iki kiganiro amabwiriza agenga imikoreshereze y’ubwo buryo bwo 
kongererera ubushyuhe abana bakivuka?) 
 
Hari ubwo wifashishije kenshi aya mabwiriza mu gihe wakoreshaga ubu buryo bushya bwo 
kongererera ubushyuhe abana bakivuka? Kubera iki/ kubera iki utayifashishaga? 
 
Aya mabwiriza yaba yanditse mu buryo bworoshye ku yumva no kuyasobanukirwa? 
 
Hari ubundi buryo ayo mabwiriza yahindurwa kugira ngo yumvikane neza ku buryo bworoshye? 
 
3) Ni gute watubwira uburyo bworoshye cyangwa se bukomeye bwo gushyushya ikiringiti cyongerera  
ubushyuhe umwana ukivuka? 

RNEC Application 
Page 52 
 
 
Byari byoroshye cyangwa byari bigoranye kubona amazi ashyushye yo gukoresha mu 
gushyushya ikiringiti 
 
Umaze gushyira uburingiti mu mazi ashyushye, cyahise gishyuha vuba? 
 
4) Ni ubuhe buryo wigeze ukoresha cyangwa wabonye abandi bakoresha mu kongerera ubushyuhe abana 
bakivuka bibasiwe n’ubukonje, uretse uburyo bwo gushyira umwana mu gituza cya nyina? 
 
Ni gute wagereranya ubu buryo bw’ikiringiti cyongerera umwana ubushyuhe n’ubundi buryo 
busanzwe bwo kongererera ubushyuhe umwana ukivuka? 
 
Waba warigeze ubona abana bato bakivuka bongererwa ubushyuhe hifashishijwe itara ryongera 
ubushyuhe? 
 
Niba wari wigeze ubona aho abana bongererwa ubushyuhe hakoreshejwe iryo tara, ucyeka ko ubu 
buryo bw’ikiringiti cyongerera abana ubushyuhe bufite akamaro/ bwizewe cyangwa nta 
kamaro/ntabwo bwizewe ugereranyije n’uburyo bwo kongerera ubushyuhe umwana 
hakoreshejwe itara? 
 
5) Ufata icyemezo gute cyo kugena igihe cyo gukoresha uburyo bw’ikiringiti cyongerera ubushyuhe 
abana bakivuka? 
 
Ese biroroshye cyangwa biragoye kubona impinduka ugendeye ku kimenyetso fatizo cy’ibara? 
 
Byaba byarakubayeho ko hari igihe utari wizeye gukoresha ikiringiti cyongerera ubushyuhe 
kubera ko icyo kiringiti cyongera ubushyuhe kitari cyateguwe? 
➢ Niba byarakubayeho: tubwire uko byagenze? 
 
6) Ni gute watubwira uburyo bworoshye cyangwa bugoye bwo gushyira umwana mu kiringiti cyongerera 
ubushyuhe umwana ukivuka nkuko wabyigishishijwe? 
 
Hari ubwo waba warahuye n’imbogamizi zo gupima ibipimo by’ubushyuhe by’umubiri 
w’umwana mu gihe umwana yari mu kiringiti cyongerera ubushyuhe umwana ukivuka? Niba 
warahuye nizo mbogamizi, tubwire uko byagenze 
 
7) Ni gute watubwira uburyo bworoshye cyangwa bugoye bwo gusukura iki kiringiti cyongerera 
ubushyuhe abana bakivuka? 
 
Bifata igihe kingana iki gusukura iki kiringiti cyongerera ubushyuhe bw’abana bakivuka? 
 
Mukura he amazi meza ndetse n’isabune mukoresha musukuru iki kiringiti cyongerera ubushyuhe 
abana bakivuka? 
 
8) Ubu buryo bw’ikiringiti cyongerera ubushyuhe abana bakivuka bwashyizweho kugira ngo bujye 
bukoreshwa mu bikorwa by’ubuvuzi bitanga nyuma yo kubyara, mu gihe cyo kuzanzamura umurwayi 
ndetse no mu gihe bamutwaye ku bitaro? Ni mu buhe buryo mwakoresheje iki kiringiti cyongerera 
ubushyuhe abana bakivuka? 
 
Mu buryo bwose wakoreshejemo ubu buryo bw’ikiringiti cyongerera ubushyuhe abana bakivuka: 
➢ Byagenze gute icyo gihe? 
➢ Haba hari uburyo wagikoresheje bikagenda neza ugereranyije n’ubundi buryo? Byagenze gute? 
 
9) Mu gihe bibaye ngombwa ko ubu buryo bw’ikiringiti bwongerera ubushyuhe bukoreshwa buri gihe 
kwa muganga, ubona hakenerwa ibiringiti byongerera ubushyuhe abana bakivuka bingahe kugira ngo buri 
gihe muhore mwiteguye mu bihe ibyo aribyo byose? 
 
Kubw’umwihariko kimwe cyakenerwa mu butabazi bw’ibanze bw’indembe? Kimwe 
kizifashishwa mu bihe bitari by’ubutabazi bw’ibanze bw’indembe? 
 
Uzakenera byumwihariko kimwe kizafashishwa mu gutwara umwana ukivuka ku bitaro? 
 
Ni uwuhe mubare munini mwagize ku birebana n’ababyeyi babyariye rimwe muri kigo 
nderabuzima? 
 

RNEC Application 
Page 53 
 
10) Hari ubwo wigeze ubona kwangirika cyangwa se impunduka ku birebana n’imiterere cyangwa se 
imikorere y’iki kiringiti cyongerera ubushyuhe abana bakivuka? 
 
Hari aho cyaba cyaracitse, cyarahiye cyangwa se indi mpinduka ku bigize iki kiringiti cyongerera 
ubushyuhe abana bakivuka? 
 
Haba hari impinduka ku birebana nuko ikimenyetso fatizo cy’ibara gihunduka mu gihe igipimo 
cy’ubushyuhe gihindutse? 
 
11) Watubwira uko iki kiringiti cyongerera ubushyuhe abana bakivuka kigaragara cyangwa se uko 
kimeze iyo umuntu agikozeho? 
 
Nta kibazo cyatera abana bakivuka? 
 
Ubona ari igikoresho kizewe bashobora gufurebamo umwana ukivuka? 
 
Ubona ababyeyi ndetse n’abandi bagize umuryango w’umwana bakira bate uburyo iki kiringiti 
cyongerera umwana ubushyuhe kigaragara cyangwa se kimeze iyo bagikoze? 
 
12) Ushingiye kubyo uzi, ubu buryo ubona bunogeye ababyeyi ku buryo babukoresha bwiyongera ku 
buryo busanzwe bwo gushyira umwana mu gituza kugira ngo ashyuhe? 
 
Niba atariko bimeze, ni ibiki bigize kiringiti cyongerera ubushyuhe abana bakivuka ababyeyi 
babona bitabanogeye? 
 
 
13) Hari ubwo ubu buryo bw’ikiringiti cyongerera ubushyuhe abana bakivuka buhindura inshuro wajyaga 
ubwira ababyeyi gukoresha uburyo bwo gushyira abana mu gituza kugira ngo bashyuhe? 
 
Haba hakiri aho ugira inama gukoresha uburyo bwo gushyira umwana ukivuka mu gatuza aho 
kubagira inama yo gukoresha uburyo bw’ikiringiti cyongerera ubushyuhe abana bakivuka? 
 
14) Haba hari ubundi buryo utekereza bwo kunoza birenzeho ubu buryo bw’ikiringiti cyongerera 
ubushyuhe? 
 
15) Haba hari ikindi kintu ushobora kutubwira ku birebana n’ubunararibonye ku mikoreshereze y’ubu 
buryo bw’ikiringiti cyongerera ubushyuhe abana bakivuka mbere yuko dusoza iki kiganiro? 
 
 
Turagushimira kuba witabiriye iki kiganiro! 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

RNEC Application 
Page 54 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix K: Infant Warmer Qualitative Interviews: Purposive Sampling Matrix 
Instructions: for each participant who agrees to an interview, check the box next to the option that fits 
best (check one option in each column). 
Health Center Name:   
Participant 
Code # 
Mode of thermoregulation (check all that apply)   
Setting of use 
Observer audit 
results 
 
IW alone            
IW+KMC + bundling 
IW+KMC      
IW+bundling 
Other_____________ 
□ Routine post-
partum 
□ Reanimation 
□ Transport 
□ Optimal use 
of the warmer 
□ 1+ usage 
mistake made 
 
IW alone            
IW+KMC + bundling 
IW+KMC      
IW+bundling 
Other_____________  
□ Routine post-
partum 
□ Reanimation 
□ Transport 
□ Optimal use 
of the warmer 
□ 1 + usage 
mistake made 
 
IW alone            
IW+KMC + bundling 
IW+KMC      
IW+bundling 
Other_____________ 
□ Routine post-
partum 
□ Reanimation 
□ Transport 
□ Optimal use 
of the warmer 
□ 1 + usage 
mistake made 
 
IW alone            
IW+KMC + bundling 
IW+KMC      
IW+bundling 
Other_____________ 
□ Routine post-
partum 
□ Reanimation 
□ Transport 
□ Optimal use 
of the warmer 
□ 1 + usage 
mistake made 
 
IW alone            
IW+KMC + bundling 
IW+KMC      
IW+bundling 
Other_____________ 
□ Routine post-
partum 
□ Reanimation 
□ Transport 
□ Optimal use 
of the warmer 
□ 1 + usage 
mistake made 
 
IW alone            
IW+KMC + bundling 
IW+KMC      
IW+bundling 
□ Routine post-
partum 
□ Optimal use 
of the warmer 

RNEC Application 
Page 55 
 
Other_____________ 
□ Reanimation 
□ Transport 
□ 1 + usage 
mistake made 
 
 
 
 
 
 
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Lawn JE, Blencowe H, Oza S, et al, for The Lancet Every Newborn Study Group. Progress, priorities and 
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6736(14)60496-7. 
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Darmstadt GL et al, Saving newborn lives in Asia and Africa: cost and impact of phased scale-up of 
interventions within the continuum of care.  Health Policy and Planning. 2008;23:101–117. 
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Hey EN, O’Connell B. Oxygen consumption and heat balance in the cot-nursed infant. Archives of Disease in 
Childhood 1970;45:335-43. 
4 
Ibe OE, Austin T, Sullivan K, Fabanwo K, Disu E, Costello AM. A comparison of kangaroo mother care and 
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Transwarmer Infant Transport Mattress. Web. 
<http://www.coopersurgical.com/ourproducts/Pages/TransWarmerInfantTransportMattress> 
6 
Green-Abate C, Tafari N et al. Comparison of heated water-filled mattress and space-heated room with infant 
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7 
 Ibe OE, Austin T, Sullivan K, Fabanwo K, Disu E, Costello AM. A comparison of kangaroo mother care and 
conventional incubator care for thermal regulation of infants <2000 g in Nigeria using continuous ambulatory 
temperature monitoring. Annals of Tropical Paediatrics. 2004;24:245–251. 
8 
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UCM348890.pdf 
9 
Fischer, Christine, Sontheimer, Dieter, Scheffer, Frank, Bauer, Jacqueline, and Linderkamp, Otwin. 
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10 Lund, Carolyn. Skin Care for ELBW Infants: Control of Transepidermal Water Loss, Use of Emollients and 
Adhesives, Skin Breakdown and Infection.  Presentation at Children’s Hospital and Research Center, Oakland 
CA, USA. 2012. 
 
 
 
 
 
 
 
 

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