The Pediatric Development Clinic Study: the Development, Medical and Nutritional Outcomes of Children Discharged From the Neonatal Unit in Rural Rwanda
Conditions: Pregnancy, Puerperium and Perinatal Conditions
Sponsor: Partners in Health

Approved by Rwanda National Ethics Committee, 9 September 2017 
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The Developmental, Medical and Nutritional Outcomes of Children Discharged from the 
Neonatal Unit in Rural Rwanda: Supporting the development of medically at-risk infants 
through the Pediatric Development Clinic 
 
Principal investigators: Hema Magge MD, MS3,5, Christine Mutaganzwa, MD1 
 
Co-Investigators: 
Catherine Kirk, MPH1, Fulgence Nkikabahizi, MD2, Merab Nyishime 1, Kim Wilson, MD3, 
Ngabireyimana Eric, MD2, Olivier Bigirumwami2, Ann Miller, PhD, MPH4, Francois 
Biziyaremye1, Scheilla Bayitondere, MD2, Jessica Bradford, MD1, Kathryn Beck, RD, MPH1, 
Emery Kwizera, MD2, Silas Havugarurema2, Patient Ngamije, MD2, Alphonse Nshimyiryo,1 
Chiquita Paula de Souza, MD1,3, Ryan McBain, ScD1 
 
Institutions: 
1. Partners In Health-Inshuti Mu Buzima (PIH-IMB), Rwinkwavu, Rwanda 
2. Rwandan Ministry of Health (MOH), Kigali, Rwanda 
3. Boston Children’s Hospital (BCH), Boston, USA 
4. Harvard Medical School (HMS), Boston, USA 
5. Brigham and Women’s Hospital (BWH), Boston, USA 
 
 
 
 
 
 
 
 
 
 
 
 

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Summary of Study (Synopsis): 
Neonatal health and improving neonatal mortality has become one of the top priorities globally.  
In Rwanda, hospital care has advanced significantly with the development of national neonatal 
care guidelines and widespread provider training. As advances in technology and resuscitation 
become more commonly available, many preterm, low birth weight and other high-risk infants 
are surviving the early neonatal period. However, upon discharge from the neonatal units, this at-
risk population has little support for their health, nutrition and development in the community.  
To address this emerging need, Partners In Health in collaboration with the Ministry of Health 
and UNICEF, has created a pediatric developmental clinic (PDC) to follow the high-risk infants 
after discharge from hospitals and health centers. Prior to implementation, a community-based 
descriptive study assessing the baseline medical, nutritional and developmental needs of low-
birth weight and preterm infants who are the target population of the pediatric development 
clinic was conducted (Baseline Phase One). Subsequently, after 1-2 years of implementation an 
evaluation of clinical, nutritional and developmental outcomes of children followed in PDC will 
be conducted in comparison with the baseline study outcomes (Post-PDC Phase Two). Ongoing 
research on PDC implementation will focus on research on patient and provider experiences, 
overall clinic processes, cost-effectiveness, expansion of the PDC model, decentralization to 
health centers, and longer term outcomes of children enrolled in the PDC to further help refine 
the PDC model (Post-PDC Phase Three).  
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
1. Background ........................................................................................................................ 5 
2. Aims of the study: ................................................................................................................. 6 
3. Methods .................................................................................................................................. 8 
3.1. Study description ........................................................................................................... 8 
3.2. Study design .................................................................................................................... 8 
3.3. Study sites ....................................................................................................................... 9 
3.4. Study population ............................................................................................................ 9 
3.5. Selection of study population ...................................................................................... 10 
3.5.1. Inclusion criteria .................................................................................................... 10 
3.5.2. Exclusion and Stop Criteria ..................................................................................... 11 
3.5.3 Sampling .................................................................................................................. 11 
3.5.4. Randomization .......................................................................................................... 12 
3.5.5. Proposed Intervention .............................................................................................. 12 
3.5.6. Recruitment Methods ...................................................................................................... 13 
3.5.7. Subjects enrollment .................................................................................................. 14 
3.6. Study Procedures .......................................................................................................... 15 
3.6.1. Procedures at enrollment and data collection. ....................................................... 15 
3.6.2. Outcomes, exposures, and confounders to be measured ....................................... 18 
3.6.3. Data Management ..................................................................................................... 22 
3.6.4. Analysis Plan ............................................................................................................. 23 
4. Study Limitations ......................................................................................................... 26 
5. Ethical Considerations ....................................................................................................... 27 
5.1. Risks and discomforts .................................................................................................. 27 
5.2. Potential benefits .......................................................................................................... 27 
5.4. Informed consent ......................................................................................................... 28 
5. Ethical approval .................................................................................................................. 29 
6. Logistics ............................................................................................................................... 29 
6.1. Distribution of responsibilities .................................................................................... 29 
6.2. Timeline ........................................................................................................................ 32 
6.3. Budget ........................................................................................................................... 33 
Acronyms ................................................................................................................................. 34 
References ................................................................................................................................ 35 
Appendix A: Household Data Collection Tools ................................................................... 37 

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Appendix B: New Tools Phase 3 ............................................................................................ 38 
Appendix C: CVs of New Investigators ................................................................................ 39 
Appendix D: Prior RNEC Approvals ................................................................................... 40 
Appendix E: Payment Receipt for August RNEC Review .................................................. 41 
Appendix F: Previously Approved Study Tools ................................................................... 42 
 
 

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1. Background 
Early childhood from birth to 5 years of age is crucial for brain development (Sices, 2007).  This 
period of growth for children is enhanced through adequate nutritional and developmental 
support. Furthermore, early intervention has been demonstrated to have significant impact on 
long-term outcomes (Childers et al, 2011). For example, early intervention has been associated 
with improved IQ in the first five years of life and has decreased behavioral problems (Nordhov 
et al, 2010), (Nordhov et al, 2012). Furthermore, studies have demonstrated that early 
intervention improves educational progression, incidence of delinquency and crime, and 
economic success (Baker-Henningham et al, 2010). Unsurprisingly, early childhood 
development support has been associated with improved outcomes of children in resource-
limited settings as well (Ertem et al, 2008). 
 
This critical time is especially important for high-risk populations, such as low- birth weight and 
preterm infants.  Infants born premature or low birth weight are at increased risk for early death, 
developmental delay and nutritional and medical comorbidities (Feldman et al, 2006). Even 
infants born in the late preterm period, after 32 weeks up until 37 weeks, are at risk for adverse 
effects on development and academic difficulties (McGowan et al, 2011). Therefore, routine 
neurodevelopmental follow-up has increasingly become the standard of care in the United States 
and Europe for these infants (McManus et al, 2012).  
 
In 2010 there were an estimated 15 million preterm (<37 weeks) births worldwide (Biencowe et 
al, 2013).  It has been estimated that approximately 1 million of these infants have some degree 
of developmental delay.  Some estimate that 200 million children in developing countries are not 
reaching their full developmental potential (Grantham-McGregor et al, 2007). 
 
Improved quality of care can help reduce this burden.  In Rwanda, up to 40% of under- five 
deaths occur within the first 28 days (Rwanda DHS 2010), and approximately 6% of all neonates 
born are low birth weight (WHO-ECDD 2012) with prematurity ranking among the top causes of 
under-five mortality (Rwanda Health Statistics, 2012).  Currently, these infants are discharged 
from hospitals with little support out in the community.   

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To address this gap, Partners In Health, in close partnership with the Rwanda Ministry of Health 
and technical support from Boston Children’s Hospital and UNICEF, is designing and 
implementing a Pediatric Development Clinic (PDC) specifically dedicated to the nutritional, 
medical and developmental concerns of this high-risk population, with the goal of improving the 
quality of life for affected infants and children. However, there is a lack of data regarding the 
current outcomes of these vulnerable newborns in resource-limited settings (Ballot et al, 2012).   
 
The proposed study aims to assess the baseline needs and disease burden of low birth weight and 
preterm infants, whom will routinely be evaluated in this clinic and will comprise a large 
majority of the clinic patients. These data will be used to inform the development and 
implementation of a pediatric developmental clinic (PDC) to follow these infants long-term, with 
the goal of improving overall pediatric health especially for those high-risk children. Following 
1-2 years of implementation, an evaluation of clinical, nutritional and developmental outcomes 
of children followed in PDC will be conducted in comparison with the baseline study outcomes. 
Additionally, the evaluation of PDC will continue after initial post-assessments focusing on 
research on patient and provider experiences, overall clinic processes, quality of care, cost of the 
PDC model, PDC training and mentorship, expansion of the PDC model, and longer term 
outcomes to further help refine the PDC model. 
 
2. Aims of the study: 
 
Phase One: Baseline/Pre-PDC 
Aim 1: To describe the baseline outcomes of a selected sample of infants discharged 
from a rural hospital neonatal unit.  This aim has been completed. 
Aim 2:  To identify specific patient-level predictors of developmental delay (if we have 
sufficient power based on prevalence of developmental delay in the sample population). 
This aim will not be completed due to the small sample size. 
 
 
 

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Phase Two: Post-PDC 
Aim 3: To describe the pediatric development clinic (PDC) implementation process after 
approximately 24 months of implementation in terms of: services provided, referral 
system, patient population served and clinical, nutritional, and developmental status.  
This aim has been completed. 
Aim 4: To describe the clinical, nutritional, and developmental outcomes of vulnerable 
patients enrolled in PDC in comparison with:  
a) Medically vulnerable infants who did not receive PDC support from Phase 
One of this study. This comparison will be made using a cohort of 
preterm/LBW children who were born in Rwinkwavu District Hospital 
(RDH) before PDC started with medical, nutritional and developmental 
outcomes assessed at 12-36 months of age. under way 
b) The general population of rural Rwandan children. This comparison will 
be looking at developmental outcomes of children followed in PDC 
compared to the same age children from the general population using 
UNICEF data that was collected in under 5 children.1  
Phase Three: Expanding PDC 
Aim 5: To evaluate the implementation of PDC during expansion, including patient 
characteristics, provider experiences, quality of care, impact of quality improvement 
interventions, cost-effectiveness, patient experiences, and patient outcomes. Findings 
from this aim will be used for continuous quality improvement of the PDC and informing 
scale-up.  
Aim 5. 1. To evaluate the implementation of interventions that promote breastfeeding 
from as early as day one of life among newborns in the referring hospital neonatal 
units.  
 
                                                 
1 The UNICEF data was conducted as part of an evaluation for UNICEF and Imbuto 
Foundation’s ECD&F Baseline. PI of this study Hema Magge and Co-I Catherine Kirk were 
both on the UNICEF ECD&F study team and have access to the study data. The ECD&F study 
was approved by RNEC (PIs Theresa Betancourt and Vincent Sezibera). 

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3. Methods 
3.1. Study description 
This study has three phases. In the first phase, descriptive study will investigate at the 
community level the developmental, medical and nutritional outcomes of infants discharged 
from the neonatal unit, aged between 12 to 36 months at the time of data collection. In the 
second phase, the study will assess the services provided to children enrolled in the PDC and 
compare their outcomes to children from the first phase as well as to an existing random sample 
of children from an existing database.  In the third phase, research will focus on answering 
questions raised from the initial PDC study aims – including patient and provider experiences, 
expansion of the PDC model, overall clinic processes, enrolment rates and retention, cost-
effectiveness, and longer term outcomes of children enrolled in the PDC to further help refine the 
PDC model and maximize benefits for children. 
 
3.2. Study design 
Pre-PDC Phase One:  
The first phase is a cross-sectional study of infants discharged from a district hospital unit using 
caregiver report of medical and developmental outcomes as well as relying on measured growth 
parameters for nutritional status. This study will serve as a baseline of developmental, medical, 
and nutritional outcomes for comparison to similar children who received services from the 
PDC.  
 
Post-PDC Phase Two:  
All under 5 years of age, high risk (preterm, LBW) children enrolled in PDC since April, 2014 
when PDC was initiated. The second phase will be a second cross-section of children who have 
been receiving services from the PDC from April 2014 when the clinic launched until present. 
The study will describe PDC implementation, demographic characteristics, and clinical, 
nutritional and developmental outcomes of all children from zero to five years of age enrolled in 
PDC from April 2014 to the time of study. 
 
Post-PDC Phase Three:  

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This phase will use mixed methods, with data sources including routinely collected data, chart 
review, household data collection, focus groups and interviews to evaluate the PDC as it expands 
to new areas. The study will provide essential information of the feasibility of the PDC model at 
larger scale. The study will describe barriers to care, retention, long-term patient outcomes, and 
provider and patient experiences, quality of care delivered in the PDC especially on growth 
monitoring and developmental screening and costing of the PDC.    
 
3.3. Study sites 
Pre-PDC Phase One:  
Phase One data collection took place in the Rwinkwavu District Hospital catchment area: 
Nyamirama, Mukarange, Mwili, Murama, Rwinkwavu, Kabarondo, Ndego, Kabare, and 
Ruramira sectors. 
 
Post-PDC Phase Two:  
Phase Two data collection will take place in the PDC clinics in the Rwinkwavu District Hospital 
catchment area: Rwinkwavu, Kabarondo, Ndego, Cyarubare and Ruramira Health Centers. 
Additional data collection on patient outcomes will be collected during household interviews at 
the homes of PDC patients.  
 
Expanding -PDC Phase Three:   
Data collection will take place in all PDC clinics in the Rwinkwavu and Kirehe District Hospital 
catchment areas. Household data collection will be conducted in the communities of Kirehe 
District.  
 
 
 
3.4. Study population  
Pre-PDC Phase One:  
All infants discharged from the Rwinkwavu District Hospital neonatal unit during the designated 
time period fulfilling the inclusion criteria: children were included if they were discharged 
between October 2011-October 2013 (prior to PDC implementation). 

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Post-PDC Phase Two:  
All children enrolled in the PDC are eligible. PDC serves children up to age five years with 
prematurity, low birth weight, birth asphyxia, other perinatal risks, and other developmental 
delays. 
 
Expanding-PDC Phase Three:   
All children and their caregivers enrolled in the PDC clinics in S. Kayonza and Kirehe Districts 
are eligible. PDC serves children up to age five years with prematurity, low birth weight, birth 
asphyxia, other perinatal risks such as post CNS infections_cerebral malaria and meningitis, and 
other developmental delays. 
 
3.5. Selection of study population 
3.5.1. Inclusion criteria 
Baseline Phase One:  
All infants discharged from Rwinkwavu hospital neonatal unit and born at less than 37 weeks 
and infants born less than 2 kilograms during the designated study period.  
 
Post-PDC Phase Two:  
All children under five years of age enrolled in PDC in Rwinkwavu District Hospital catchment 
area PDC clinics, will be included in Aim 3 and Aim 4b. Aim 4a will include only preterm 
and/or LBW (<2000g) infants for comparison with the baseline population of similar infants. 
 
Expanding-PDC Phase Three:  
All children under five years of age and their caregivers referred to or enrolled in PDC in 
Rwinkwavu and Kirehe District Hospital catchment areas. In addition, newborns and their 
caregivers from Rwinkwavu and Kirehe District Hospital catchment areas will be included as the 
primary referral patient population to PDC. PDC providers will also be included in some 
components of the evaluation.  
 

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3.5.2. Exclusion and Stop Criteria 
Pre-PDC Phase One: 
1. Any infant whose family is unwilling to consent to study or decides to stop the home visit 
at any time. 
2. Congenital heart disease per neonatal register 
3. Genetic dysmorphology per neonatal register 
4. Birth asphyxia per neonatal register 
 
Post-PDC Phase Two: 
1. For Aim 4a, exclusion criteria will match the Baseline Phase One exclusion criteria listed 
above.  
 
Expanding-PDC Phase Three: 
1. Children who do not meet inclusion criteria will be excluded.  
 
3.5.3 Sampling  
Pre-PDC Phase One:  
Potential participants will be identified and sampling will be conducted in the following manner. 
The study coordinator will use the Rwinkwavu neonatal registry after obtaining consent from the 
medical director to identify potential study participants based on the inclusion criteria outlined 
above.  The following identifiers will be extracted from the registry: name, sex, date of birth, 
discharge date and mother’s name.  After the identification of potential participants, the patient 
files will be located and examined to compile the demographic information of the infants: sector, 
cell, village, and health center.  
 
Post-PDC Phase Two:  
All children enrolled in the PDC are eligible and no new data will be collected for Aim 3. 
Children will be identified through PDC patient records, which include patient registers, patient 
enrollment forms, routine program forms, and the electronic medical record (EMR). To complete 
Aim 4, additional assessments of children’s growth, development, and home environment 
including parenting practices will be conducted through household interviews with the primary 

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caregivers of PDC patients. Patient names and household location will be extracted from the 
EMR of patients who enrolled in the PDC at least 12 months prior to data collection.  
 
Expanding-PDC Phase Three:  
All children enrolled in the neonatal units or PDC, their caregivers, and PDC providers are 
eligible for participation in this aim. Children will be identified through neonatal unit and PDC 
patient records, which include patient registers/charts, patient enrollment forms, routine program 
forms, and the electronic medical record (EMR).  
 
3.5.4. Randomization 
None  
 
3.5.5. Proposed Intervention  
Children in Phases Two and Three of this study have participated in the PDC program as 
described previously, unless they are in a comparison group. The PDC provides medical, 
nutritional and developmental supportive programs to at-risk children under age five using 
trained nurses and social workers in addition to overall clinic supervision by a general 
practitioner. Children are referred to the PDC from the hospital (neonatal unit, maternity, 
inpatient pediatrics, and the outpatient or emergency departments), health centers, and from the 
community. Children are eligible to enroll in the PDC if they meet the following program 
eligibility criteria: prematurity, low birth weight (<2000grams), hypoxic ischemic 
encephalopathy, hydrocephalus, cleft lip and palate, trisomy 21, post central nervous system 
infections (meningitis and cerebral malaria) severely malnourished children requiring 
hospitalization post-discharge, as well as children presenting with other developmental delays. 
Children come in for routine visits, on a timeline determined by their specific condition. On each 
PDC clinic day, social workers facilitate a group counseling session focused on topics relevant to 
children’s growth and development. After group sessions, children undergo a clinical screening 
and growth monitoring by a nurse as well as one-on-one sessions with a social worker to identify 
needs for additional social support whether financial, emotional, nutritional, or a home visit. 
PDC social support groups are formed to engage father’s in the care of their children. Health 

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center PDC clinics receive mentorship visits from the hospital PDC supervision team; mentors 
use structured observation checklists for monitoring quality of care delivery and data-feedback.  
An application to aid decision making using tablets has been designed to address challenges with 
growth monitoring especially for preterm infants and identification of feeding difficulties, which 
has limited the PDC’s ability to successfully provide early intervention in cases of growth 
failure. The mHealth tool supports providers in calculating z-scores, interval growth, and 
adjusted age as well as providing counseling that is tailored to the individual child’s needs. Also, 
in an effort to optimize nutritional outcomes of babies discharged from Rwinkwavu and Kirehe 
Neonatal Units, as part of phase 3 of the project, we will also be implementing interventions to 
promote breastfeeding from as early as day one of life. This will primarily be done through early, 
individualized counseling and education on the importance and best techniques for breastfeeding 
and expressing breast milk, but will also employ visual aids such as posters and videos, and the 
institution of a policy to restrict use of artificial milk to clinically indicated situations, such as 
growth failure that requires breast milk supplementation to provide additional calories, or within 
the first two weeks of life if the mother has insufficient breast milk production, to avoid negative 
effects on growth. By targeting mothers and infants in the Neonatal Unit to establish strong 
breastfeeding during admission, growth of high-risk infants will be optimized from day one of 
life, and babies will also experience additional benefits of breast milk such as reduced infections 
and improved neurodevelopmental outcomes before they are discharged for follow-up in PDC. 
Future, planned interventions are to promote maternal nutrition by providing supplementary 
meals and involving our maternity department in counseling mothers on early initiation of 
breastfeeding for all babies, and expressing breast milk for babies who are unable to breastfeed 
due to prematurity or their clinical status.  
 
3.5.6. Recruitment Methods 
Pre-PDC Phase One:  
Our data collection is based on the use of independent data collectors. Data collection officers 
will be identified from the Family Strengthening Intervention Study staff (through coordination 
with their study coordinator) and will be trained on the use of the Ages and Stages Questionnaire 
as well as weight, length and head circumference measurements. Training sessions will take 
place at Rwinkwavu Center for Training and Operational Research. After completion of training, 
the data collection officers will be given a list of potential study participants.  The data officers 

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will then contact the family’s community health worker prior to making home visits and 
approaching the family for study participation.   
 
Post-PDC Phase Two: All children enrolled in the PDC are eligible and the study will use 
routinely collected data from patient charts and EMR. In addition, patients who have been seen 
in the PDC clinic for 12 or more months will be contacted to participate in a household interview 
to be conducted by trained, independent data collectors. Patients will be identified from PDC 
enrollment records, and information will be extracted from patient charts for follow-p in the 
community (this includes caregiver name, geographic location of the household, and any relevant 
contact information for the household such as a phone number). Data officers will then contact 
the family’s community health worker prior to making home visits and approaching the family 
for study participation.   
 
Expanding-PDC Phase Three:  
All children enrolled in the hospital neonatal units or PDC, and their caregivers, are eligible. The 
study will use routinely collected data from patient registers, patient charts and EMR in addition 
to qualitative methods. In addition, a list of PDC-eligible children prior to the opening of PDC in 
Kirehe (i.e., before May 2016) will be identified for household data collection to establish 
baseline status of high-risk infants prior to PDC. PDC providers (nurses, doctors, social workers, 
other parahealth professionals, volunteers) will be eligible to participate if they have been 
working in the PDC for at least 3 months. 
 
3.5.7. Subjects enrollment 
Pre-PDC Phase One:  
After consent obtained from the caregiver by the data collector, the study participant will be 
enrolled and data collection will begin.  All patient data will be stored in a password-protected 
access database. 
 
Post-PDC Phase Two:  

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All children enrolled in the PDC are eligible and the study will use routinely collected data. 
Informed consent will be obtained for all participants who enrolled in PDC at least 12 months 
prior to data collection that willing to participate in household data collection.  
 
Expanding-PDC Phase Three:  
All children enrolled in the neonatal unit or PDC, and their caregivers, are eligible and the study 
will use routinely collected data. When routinely collected data is being used, we will not 
conduct additional informed consent. For any additional data collection with caregivers using 
qualitative methods or household data collection, caregivers will provide written informed 
consent for themselves and their child. Any PDC provider who participates in the study will 
provide written informed consent.  
 
3.6. Study Procedures 
3.6.1. Procedures at enrollment and data collection.  
Pre-PDC Phase One:  
After consent is obtained, data will be collected using a data collection form and the ASQs from 
12 to 36 months of age on an Android tablet. The ASQ is a validated screening tool for child 
development that has also been translated to Kinyarwanda and validated for local use. The Ages 
and Stages questionnaire went through a validation process with the publisher to adapt the 
screening tool to Rwanda.  The questionnaire was first translated from English to Kinyarwanda.  
After translation the questionnaire was field-tested.  The questionnaire was then adapted to 
Rwandan cultural context and underwent field-testing again.  The ASQ went through a final 
adaptation to Rwandan culture and was translated to English.  It was then back translated to 
Kinyarwanda and finally submitted to the publisher for approval. Questions will be in a simple 
yes/no format and growth parameters of weight, height, head circumference and MUAC will be 
measured.  Questions will be asked about the medical complications and developmental 
milestones will be assessed using the ASQs per age group.  Upon data collection completion, the 
growth parameters and medical comorbidities will first be entered into the database and then the 
ASQ will be scored by a study staff.  The scoring of the ASQ will be based on the answers of the 
caregivers.  A score will be given to each answer. The ASQ has three possible answers: yes, not 
yet, or sometimes. At the end of the questionnaire the total score will be tabulated for each of the 

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five subsections based on a standard scoring methodology.  Depending on the score, the 
questionnaire will be counted as normal or abnormal (developmental delay present).  
Developmental delay will be defined as any single domain score that falls within the limits of 
concern or delay according to the ASQ scoring table at the end of the questionnaire.   
 
Post-PDC Phase Two:  
The majority of phase two data comes from existing program records, both paper-based and 
electronic as well as pre-existing de-identified data. The procedure is as follows for using 
routinely collected program data: After RNEC and MOH approvals are obtained, data will be 
collected from electronic medical records (EMR) and paper forms that are part of routine 
programmatic record keeping (See Appendix F for complete list of PDC routine data collection 
forms approved; new routine forms are contained in Appendix B). Demographic characteristics, 
anthropometric measurements, clinical, nutritional and developmental outcomes information will 
be extracted from the PDC EMR dataset and patient files. After extraction from the original 
dataset, data will be transferred into STATA (Stata Corp, College station, Texas, USA) for data 
cleaning and further statistical analysis. Patient identifiers will be removed and unique 
identification numbers will be assigned to the working dataset to respect patient confidentiality.  
As Aim 3 is a secondary dataset analysis of de-identified patient records, no individual patient 
consent procedure will be needed.  
Aim 4 will include household interviews with caregivers of children who enrolled in PDC at 
least 12 months prior to data collection (see study tools for household data collection in in 
Appendix A). These patients will be identified using EMR records and will be asked if they are 
willing to be contacted by the study team by PDC staff. If a caregiver is willing to participate, 
he/she will be contacted by the study team and complete informed consent prior to data 
collection. Consenting participants will complete an interview about the child’s development, 
nutrition, parenting, and the home environment (see Appendix A for household data collection 
tool). Child development will be measured using the Ages and Stages Questionnaire, as has been 
previously approved for use in this study protocol. Appendix A contains all 20 age-specific 
forms of the Ages and Stages Questionnaires, however each caregiver will be asked only the 30 
age-specific questions that are appropriate for their child; all questions for children of different 
ages will be skipped. Data will be collected on Android tablets using the software platform 

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KoboCollect. 
 
Expanding-PDC Phase Three:  
The majority of phase three data comes from existing program records, both paper-based and 
electronic as well as pre-existing de-identified data (see Appendix B for new tools being used in 
the PDC; Appendix F contains all the tools previously approved by RNEC). Additional data will 
be collected through household data collection and qualitative methods (new tools contained in 
Appendix B).  
 
The procedure is as follows for using routinely collected program data: Data will be collected 
from electronic medical records (EMR) and paper forms that are part of routine programmatic 
record keeping (See Appendices B and F for all PDC data collection forms). Demographic 
characteristics, anthropometric measurements, clinical, counseling assessments, nutritional and 
developmental outcomes information will be extracted from the PDC EMR dataset and patient 
files. After extraction from the original dataset, data will be transferred into STATA (Stata Corp, 
College station, Texas, USA) for data cleaning and further statistical analysis. Patient identifiers 
will be removed and unique identification numbers will be assigned to the working dataset to 
respect patient confidentiality.  
 
For household data collection, the procedure is as follows: neonatal unit registers will be 
reviewed for patients who would have been eligible for the PDC prior to the opening of the PDC 
in May 2015. Eligible caregivers of patients who were discharged alive will be contacted in the 
community to ask if they are willing to participate in the study. If caregivers provide written 
informed consent, they will be interviewed by trained data collectors using Android tablets about 
the current health, nutritional, and developmental status of their child as well as questions on the 
family environment. Household data collection tools are contained in Appendix A. 
 
For qualitative data collection with PDC providers and patient caregivers, they will be invited by 
study staff (not PDC providers) to participate in focus groups and/or individual interviews. Only 
those who provide written informed consent will participate and interviews and/or focus groups 

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will be conducted at Partners In Health offices or other private spaces away from the PDC 
clinics.  
 
When evaluating cost data, we will also access routine financial reports from Partners In Health 
and the Ministry of Health to assess program costs such as supplies, equipment, staffing, patient 
costs, supervision costs, and other inputs required for the PDC program.  
 
3.6.2. Outcomes, exposures, and confounders to be measured 
 
Pre-PDC Phase One: 
Aim 1: Describe the baseline outcomes of a selected sample of infants discharged from a 
rural hospital neonatal unit. 
 
1. Primary Outcome:  
The primary outcome is the proportion of study participants alive with developmental 
delay.  
Developmental delay is defined as one domain that is scored as an area of concern or 
presence of delay using the Ages and Stages Questionnaire (ASQ-3).  
 
2. Secondary Outcomes: 
1. Proportion of study subjects deceased 
2. Proportion of study subjects with malnutrition 
3. Proportion of study subjects with medical co-morbidities, further broken down 
into the four categories: hydrocephalus, anemia, feeding difficulty, and respiratory 
disease.  
4. Proportion of the study subjects with developmental delay and malnutrition  
5. Proportion of study subjects with developmental delay and medical comorbidities 
 
Aim 2: Identify specific patient-level predictors of developmental delay. Main exposures of 
developmental delay include prematurity, low birth weight and malnutrition. Potential 

Approved by Rwanda National Ethics Committee, 9 September 2017 
19 
 
confounders include but not limited to sector of residence, sex, ubudehe category (measure of    
economic status), household size, and education level. 
 
Post-PDC Phase Two:  
Aim 3: Describe the PDC. This aim is to describe the pediatric development clinic (PDC) 
after 24 months of implementation in terms of the following main outcomes: services 
provided, referral system, patient population served and clinical, nutritional, and 
developmental status after support and follow-up in the clinic. 
 
Other Variables to be measured include (See Appendix F for data source 
forms) 
Characteristics of Clinic Patients 
Proportion of study participants per age category and per medical condition. 
Broken down by:  
- 
Proportion of infants 
- 
Proportion of children from one year to five years  
- 
Proportion of children born premature 
- 
Proportion of ELBW/ VLBW 
- 
Proportion of infants born at term with HIE or cerebral infection 
Proportion of children with developmental delays, trisomy 21, hydrocephalus, 
cleft lip/palate, and developmental delay 
- 
Proportion of children deceased 
- 
Proportion of children lost to follow-up 
- 
Proportion of children with malnutrition per age category or per 
medical condition 
 
Clinic activities will be described  
 Patient flow: Group education, individual social worker screening, clinical 
evaluation including danger sign assessment, nutritional 
assessment/classification/treatment, developmental screening/therapy, and 
condition-specific screening and treatment.  

Approved by Rwanda National Ethics Committee, 9 September 2017 
20 
 
 
Aim 4: Compare developmental, medical, and nutritional outcomes of children who were 
enrolled in the PDC to other children on the main outcomes of prevalence of 
developmental delay as measured using the Ages and Stages Questionnaires (ASQ-3) and 
the prevalence of undernutrition (stunting, wasting, underweight) using anthropometric 
assessments. 
 
This aim is to describe the clinical, nutritional, and developmental outcomes of 
vulnerable patients enrolled in PDC in comparison with:  
a. Medically vulnerable infants who did not receive PDC support. This 
comparison will be made using a cohort of preterm/LBW children who 
were born in Rwinkwavu District Hospital (RDH) before PDC started with 
medical, nutritional and developmental outcomes assessed at 12-36 
months of age (the dataset from Aim 1).  
b. The general population of rural Rwandan children.2  This comparison will 
be looking at developmental outcomes of children followed in PDC 
compared to the similar age children from the general population using 
UNICEF data that was collected in children ages 0-11 months and 24-35 
months randomly sampled from ten rural sectors of the country. 
 
Additional variables to be measured include (See Appendix F for data source forms 
of routinely collected data and Appendix A for household interview forms. All 
measures used in the household interview were previously used in the two 
comparison datasets): 
- 
Descriptive characteristics of caregivers. 
- 
Proportion of visits where a nutritional screening was done, danger sign 
screening was done, and patient had a documented ASQ within the 6 
months prior to visit date.  
                                                 
2 This existing data set was collected by UNICEF, Harvard School of Public Health, Partners In 
Health, and the University of Rwanda. Dr. Hema Magge and Catherine Kirk were investigators 
on both study teams and have access to the data. 

Approved by Rwanda National Ethics Committee, 9 September 2017 
21 
 
- 
Proportion of children who received nutrition supplement.  
- 
Proportion of currently enrolled children with a visit in the reference 
quarter whose caregivers have had at least one documented ECD 
counseling session 
- 
Proportion of children with moderate or severe chronic malnutrition 
(height/age Z score < 2 or height/age z score < 3) at the last visit. 
- 
Proportion of children with moderate or severe acute malnutrition 
(weight/height Z score < 2 or weight/height z score<3) at the last visit. 
- 
Proportion of children with a completed and documented ASQ in the 
reference quarter failing one or more domains on the ASQ.  
- 
Mean/median scores on the overall ASQ  
- 
Mortality rate in both groups  
- 
Percentage of patients lost to follow-up 
- 
Opportunities for learning and stimulation in the home, measured by the 
Rwanda-adapted HOME Inventory and the Rwanda DHS Early Childhood 
Development Index 
- 
Caregiver mental health, measured by the Hopkin’s Symptom Checklist 
which has been validated in Rwanda and used in Rwanda to assess 
symptoms of depression and anxiety for over twenty years  
- 
Caregiver-child interactions and discipline practices, using the 
Kinyarwanda version of the Observations of Mother-Child Interactions 
(OMCI) as well as the Rwanda DHS Child Discipline Module 
- 
Socioeconomic status of the household, using wealth index from the 
Rwanda DHS 
- 
Expoure to daily hardships and household stressors 
 
Expanding-PDC Phase Three: 
Aim 5: To evaluate the implementation of PDC during expansion, including patient 
characteristics, provider experiences, quality of care, cost-effectiveness, patient experiences, and 
patient outcomes. Findings from this aim will be used for continuous quality improvement of the 
PDC and informing scale-up.  

Approved by Rwanda National Ethics Committee, 9 September 2017 
22 
 
 
Primary Outcome: The primary outcome is the proportion of study participants alive 
who are meeting developmental and growth milestones.   
 
Secondary Outcomes: 
o Cost-effectiveness of the PDC model 
o Adherence to PDC care protocols by PDC providers 
o Quality of care 
o Enrollment rates, clinic retention, and barriers to care 
o Patient and provider experiences 
o Impact of training and mentorship in the PDC protocol 
o Evaluation of improved exclusive breastfeeding prior to PDC referral 
o Impact of PDC mHealth tool on protocol adherence and child growth 
o Impact of PDC on child outcomes in Kirehe 
 
 
3.6.3. Data Management 
For all phases, patient identifiers will be removed and a separate linking file will be kept in a 
password-protected computer with access only by the study staff to allow for data quality 
assessments of the EMR. All data will be kept in a password-protected database. 
 
Pre-PDC Phase One: 
After collection of the completed data forms, all information will be uploaded into a password-
protected database.   
 
Post-PDC Phase Two: 
Data will be extracted from the EMR system and exported into Stata for statistical analysis. All 
participants will be assigned a study ID. Any additional data that is not in the EMR will be 
entered from paper-based patient files into a database for data management and cleaning. 
Additional paper-based data extracted from patient charts and entered into KoboCollect will be 
merged into the EMR databased by linking study IDs (Aim 3). Data on PDC patients for Aim 4 

Approved by Rwanda National Ethics Committee, 9 September 2017 
23 
 
will be extracted from the EMR and/or additional patient records and data from household 
interviews will be collected using KoboCollect and securely stored with an SSC connection and 
password protection. Data on PDC patients will be appended to de-identified comparison 
datasets for study aims 4a and 4b for analysis.  
 
Expanding-PDC Phase Three: 
Data will be extracted from the EMR system and exported into Stata for statistical analysis. All 
participants will be assigned a study ID. Any additional data that is not in the EMR will be 
entered from paper-based patient files or gathered through interviews into KoboCollect, or other 
comparable software, database for data management and cleaning. Additional paper-based data 
extracted from patient charts and entered into KoboCollect will be merged into the EMR 
databased by linking study IDs. Cost-data will also be entered into a KoboCollect, or other 
comparable software, database for data management and cleaning. Qualitative data will be 
collected using audiorecorders. Kinyarwanda transcripts of recorded interviews and focus groups 
will be translated into English for analysis.  
 
3.6.4. Analysis Plan 
 
Pre-PDC Phase One:  
Aim 1: Describe the baseline outcomes of a selected sample of infants discharged from a rural 
hospital neonatal unit.  
Analysis Plan: 
The primary analysis will be a univariate analysis describing the proportion of children 
discharged from the neonatal unit with developmental delay at two years of age.  This is 
the primary outcome of the study and will provide vital data regarding neonatal outcomes 
at two years after discharge from neonatal unit. Proportions will be calculated for 
categorical variables and means with standard deviations will be calculated for 
continuous variables.   
Categorical variables include: sex, sector, alive/dead, malnutrition (yes/no), malnutrition 
category (low, moderate, severe), medical comorbidities (anemia, respiratory disease, 

Approved by Rwanda National Ethics Committee, 9 September 2017 
24 
 
possible hydrocephalus, and feeding difficulty), ubudehe category (measure of economic 
status), and education level of the caregiver. 
Continuous variables are birth weight, gestational age, age at the time of data collection, 
and household size. 
 
Aim 2: Identify specific patient-level predictors of developmental delay            
Analysis Plan: 
We hypothesize that birth weight (< 1kg, 1-1.5kg, 1.5-<2kg, ≥ 2 kg), gestational age (<32 
weeks, 32-36weeks, ≥ 37weeks), and malnutrition (yes/no) will be significantly 
associated with developmental delay in bivariate and multivariable analyses.    
 
Chi square test will be performed to test for associations between these categorical 
variables and the primary outcome (developmental delay). A multivariable logistic 
regression model will be created to identify predictors of developmental delay controlling 
for potential covariates using the same list of descriptive variables.  However, this 
analysis will only be performed if there are a sufficient number of children with the 
primary outcome to have sufficient power to detect predictors.    
 
Post-PDC Phase Two:  
Aim 3: Describe the PDC and patients enrolled in the PDC  
Analysis Plan: 
Demographic characteristics, services provided to patients, and clinical, nutritional and 
developmental outcomes will be described using descriptive statistics. For continuous 
variables, mean and standard deviations will be reported unless the distribution is not 
normal and then medians and inter-quartile range will be reported. Frequencies and 
percentages will be reported for categorical variables.   
 
Aim 4a: Compare developmental, medical, and nutritional outcomes of children who were 
enrolled in the PDC to medically vulnerable children who did not receive PDC support (from 
Baseline Phase One) 
Analysis Plan: 

Approved by Rwanda National Ethics Committee, 9 September 2017 
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We will use bivariate analyses to compare the outcomes of infants who received PDC 
services with those who did not receive these services (the baseline data from Phase 
One). Developmental delay will be scored as a binary outcome looking at the proportion 
of children who failed one or more ASQ-3 domain at baseline to the proportion of 
children enrolled in PDC who failed one or more ASQ-3 domain. We will use a chi 
square test or fishers exact test look for significant differences in the number of children 
with developmental delay between children who received PDC services and those who 
did not. Chi squared or fishers exact tests will also be used to assess for differences in 
nutritional outcomes (normal, moderate, and severe malnutrition indicators) and medical 
outcomes among the two groups. 
If we have sufficient power, we will conduct logistic regression analyses to look at 
predictors of developmental delay in the sample. Using backwards selection, all variables 
associated with developmental delay at p < 0.10 in bivariate will be included in the full 
model. We will report Odds Ratio, p-value, and 95% confidence intervals for multivariate 
analyses. 
 
Aim 4b: Compare developmental, medical, and nutritional outcomes of children who were 
enrolled in the PDC to a sample of Rwandan children from ten rural sectors across the country. 
Analysis Plan: 
We will use bivariate analyses to compare the outcomes of infants who received PDC 
services with a random sample of children from rural communities in Rwanda (a pre-
existing dataset). Developmental delay will be scored as a binary outcome looking at the 
proportion of children who failed one or more ASQ-3 domain in the random sample of 
Rwandan children from rural areas to the proportion of children enrolled in PDC who 
failed one or more ASQ-3 domain. We will use a chi square test or fishers exact test look 
for significant differences in the number of children with developmental delay between 
children who received PDC services and those who did not. We will use chi squared or 
fishers exact test to assess for differences in nutritional (normal, moderate, and severe 
malnutrition indicators) among the two groups. Medical outcomes will not be assessed 
because the comparison database only collected data on demographics and current 

Approved by Rwanda National Ethics Committee, 9 September 2017 
26 
 
developmental and nutritional status.   
 
Expanding-PDC Phase Three:  
Aim 5: Analyses of PDC expansion will be focused on descriptive analyses of process, output 
and selected outcome measures including, patient outcomes, quality of care, and quality 
improvement interventions according to defined standards, training and mentorship activities, 
referral rate, retention, barriers and facilitators to care, patient and provider experiences, and 
patient health, nutritional, and developmental outcomes. These data will be used to monitor 
impact of PDC on patient outcomes as well as continuous quality improvement of the model, 
such as the introduction of the new mHealth application to improve quality of growth 
monitoring. As appropriate, bivariate and multivariate analyses will be used. Qualitative analysis 
will use thematic coding. 
 
Aim 5. 1. Descriptive analyses to evaluate the implementation of interventions to promote 
breastfeeding from as early as day one of life among newborns in the referring hospital neonatal 
units will focus on analysis of exclusive breastfeeding rates and proportion of newborns 
requiring formula pre-post quality improvement interventions.  
 
4. 
Study Limitations 
Pre-PDC Phase One: 
1. Data is based on caregiver report and therefore subject to recall bias of the caretakers.    
2. The high-risk infants who were hospitalized in the neonatal unit were not from one 
specific sector.  The Rwinkwavu Neonatal unit serves as a referral center for the Southern 
Kayonza district.  Each of the sectors within the district may not be environmentally 
identical.  Specifically the availability of food, amount of rain and distance to health 
centers are factors that could influence the outcomes of the high-risk neonates and 
therefore could result in residual confounding. 
3. The gestational age and birth weight are subject to misclassification.  
4. This is cross sectional data, and therefore any associations found are unable to assess 
causality. 
5. Exclusion criteria undiagnosed by register are subject to misclassification.  

Approved by Rwanda National Ethics Committee, 9 September 2017 
27 
 
 
Post-PDC Phase Two: 
1. This study will be a cross-sectional study, and therefore associations may be found, but 
we will be unable to assess causality. 
2. For the Aim 4b comparing PDC participants and UNICEF sample, only similar age 
groups will be compared; therefore, the number of children may be reduced which might 
affect the power of the study and its external validity. 
3. As this is a secondary dataset analysis, missing values are expected.  
4. The gestational age and adjusted age are subject to misclassification due to recall bias. 
 
Expanding-PDC Phase Three:  
1. As this is primarily a secondary dataset analysis of routinely collected data, missing 
values are expected.  
 
5. Ethical Considerations 
5.1. Risks and discomforts 
Breach of confidentiality is a potential risk. Section 6.3 illustrates how we will address this. 
 
5.2. Potential benefits 
Pre-PDC Phase One: 
This study offers potential direct benefits to the patients participating in the study, as patients 
identified with medical or nutritional abnormalities will be referred to appropriate services (in 
addition to future enrollment in the Pediatric Development Clinic if applicable). Participation 
offers the indirect benefit of providing key insights into creation of a patient-centered Pediatric 
Development Clinic.    
 
Post-PDC Phase Two: 
There are no direct benefits to the patients included in the study. However, there are indirect 
benefits as the study will allow us to better understand the services provided, medical, 
nutritional, developmental, and social needs of the patients enrolled in PDC, the quality of care 
delivered in the clinic, and therefore be used to improve services to the overall PDC patient 

Approved by Rwanda National Ethics Committee, 9 September 2017 
28 
 
population. In addition, the study sample consists primarily of PDC patients who are benefiting 
from the PDC intervention, including the provision of essential social supports such as food 
packages for eligible patients.  
 
Expanding-PDC Phase Three:  
There are no direct benefits to the patients included in the study. However, there are indirect 
benefits as the study will allow us to better understand the services provided, medical, 
nutritional, developmental, and social needs of the patients enrolled in PDC, the quality of care 
delivered in the clinic, and therefore be used to improve services to the overall PDC patient 
population. In addition, the study sample consists primarily of PDC patients who are benefiting 
from the PDC intervention, including the provision of essential social supports such as food 
packages for eligible patients. 
 
5.3. Confidentiality 
Data will be stored securely and entered into a de-identified, password protected database with 
access limited to the investigative group. EMR data is only accessible to MOH care providers, 
approved PIH/IMB staff members working with the EMR, as well as study staff. Paper records 
(consent forms and any paper-based data collection) will be stored in a locked cabinet and 
destroyed after two years. Patient identifiers, such as names, will be removed from final research 
databases. 
 
5.4. Informed consent 
 
Pre-PDC Phase One: 
A written consent form will be administered to all caregivers by the data collection officer. 
Participants will be informed that their decision to participate or to not participate will have no 
effect on the medical care that they receive from their community cell supervisor or health 
centers. The participant may stop the data collection at any point.  The data collectors selected to 
collect the data will be compensated for their time irrespective of the forms completed in order to 
prevent any coercion to participate. 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
29 
 
Post-PDC Phase Two: 
Aim 3 will be using routinely collected data and analysis of existing datasets consent will be 
obtained. The existing datasets for comparison groups identified in Study Aim 4a and 4b were 
both conducted, as household surveys where caregivers provided written informed consent. In 
addition, patients contacted in Aim 4 for household data collection will complete informed 
consent for themselves and their child. 
 
Expanding-PDC Phase Three:  
All children enrolled in the PDC, and their caregivers, are eligible and the study will primarily 
use routinely collected data. When routinely collected data is being used, we will not conduct 
additional informed consent. Any PDC provider who participates in the study will provide 
written informed consent. Any caregiver who participates in non-routine data collection 
(qualitative evaluation components or household interviews), will provide written informed 
consent for themselves and their child. 
 
5. Ethical approval 
Ethical approval will be obtained from the Rwanda National Ethics Committee and Boston 
Children's Hospital (BCH) Institutional Review Board. Technical approval will be sought from 
Inshuti Mu Buzima Research Committee and Rwanda National Health Research Committee.  
 
6. Logistics 
6.1. Distribution of responsibilities 
Mutaganzwa Christine, MD: Overall study supervision, input on study design, data collection 
oversight, ASQ scoring, data analysis and interpretation, manuscript writing and review. Partners 
In Health, 10%.  
 
Catherine Kirk, MPH: Overall study supervision, input on study design, data collection 
supervision, data analysis, data interpretation, manuscript writing and review and mentorship of 
junior researchers on the PDC team. Partners In Health, 5% time. 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
30 
 
Hema Magge MD, MS: Input on study design, data collection oversight, review of data analysis 
and interpretation, manuscript writing and review. Boston Children’s Hospital, 2.5% time. 
 
Merab Nyishime: Input on study design, oversight of eligibility determination and sampling 
strategy, data interpretation, manuscript writing and review. Partners In Health, 2.5% time.  
 
Fulgence Nkikabahizi, MD: MOH study supervisor, data collection supervision, data 
interpretation, Manuscript preparation and review.  Rwanda Ministry of Health 2.5% 
  
Eric Ngabireyimana, MD: Input on study design, data interpretation and manuscript review. 
Manuscript preparation and review.  Rwanda Ministry of Health 2.5% 
 
Olivier Bigirumwami: Input on study design, data interpretation and manuscript review. 
Manuscript preparation and review.  Rwanda Ministry of Health 2.5% 
 
Kim Wilson, MD: Input on study design, data interpretation, and manuscript preparation.  
Boston Children’s Hospital, 2.5% time 
 
Ann Miller, PhD, MPH: Input on study design, data analysis and interpretation, manuscript 
writing and review, and mentorship of junior researchers on the PDC team. Harvard Medical 
School, 2.5% time. 
 
Francois Biziyaremye: Input on study design, data analysis and interpretation, manuscript 
writing and review. Partners In Health, 2.5% time. 
 
Scheilla Bayitondere, MD: Input on study design, data analysis and interpretation, manuscript 
writing and review. Ministry of Health, 2.5% time. 
 
Jessica Bradford, MD: Input on study design, data analysis and interpretation, manuscript 
writing and review. Partners In Health, 2.5% time. 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
31 
 
Kathryn Beck, RD, MPH: Input on study design, data analysis and interpretation, manuscript 
writing and review. Partners In Health, 2.5% time. 
 
Emery Kwizera, MD: Input on study design, data analysis and interpretation, manuscript 
writing and review. Ministry of Health, 2.5% time.  
 
Silas Havugarurema: Input on study design, data analysis and interpretation, manuscript 
writing and review. Ministry of Health, 2.5% time. 
 
Patient Ngamije, MD: Input on study design, data interpretation, and manuscript review. 
Ministry of Health, 2.5% time. 
 
Alphonse Nshimyiryo: Input on study design, leading all data analysis and interpretation, 
manuscript writing and review. Partners In Health, 25% time. 
 
Chiquita Palha De Souza, MD: Input on study design, data analysis and interpretation, 
manuscript writing and review. Partners In Health and Austin Children’s Hospital, 2.5% time. 
 
Ryan McBain, ScD: Input on study design, advisor for data analysis, manuscript writing and 
review. Partners In Health and Austin Children’s Hospital, 2.5% time. 
 
 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
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6.2. Timeline 
 
Pre-PDC Phase One 
  
  
  
  
  
  
Period (months) 
Oct - 
Nov 
Dec ’13- 
Nov - 
Dec 
Jan - 
Feb 
Mar - 
May 
Activities 
2013 
Jul ‘15 
2015 
2015 
2015 
IMBRC/NHRC/MOH/Hospital approvals  
  
  
  
  
  
Data collection and entry 
  
  
  
  
  
Data analysis and interpretation of results 
  
  
  
  
  
Preparation of manuscript 
  
  
  
  
  
Paper submission for publication  
  
  
  
  
  
Post-PDC Phase Two 
Period (months) 
Jun - Jul 
Aug -
Oct 
Nov-
Dec 
Jan - 
Feb 
Mar - 
May 
Activities 
2015 
2015 
2015 
2016 
2016 
Protocol amendment  
  
  
  
  
  
Data extraction for the aim 3 
  
  
  
  
  
Data extraction for the aim 4 
  
  
  
  
  
Data analysis and interpretation of results 
  
  
  
  
  
Preparation of manuscript  
  
  
  
  
  
Paper submission for publication  
  
  
  
  
  
 
Expanding-PDC Phase Three:  
Period (months) 
October 
Nov-
Dec 
Jan-Jun 
Jul-Dec 
2018 
and 
Activities 
2016 
2016 
2017 
2017 
on 
Protocol amendment  
  
  
  
  
  
First expansion of PDC to Kirehe Health 
Centers 
  
  
  
  
  
Routine data extraction for aim 5 
  
  
  
  
  
Household data collection for aim 5 
 
 
 
 
 
Data analysis and interpretation of results 
  
  
  
  
  
Preparation of manuscript(s) 
  
  
  
  
  
 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
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6.3. Budget 
Pre-PDC Phase One 
Activity                               
 Unit Cost 
(RWF)  
Total number    
Total cost 
(RWF) 
RNEC Application 
850,000 
1 
850,000 
NHRC Application  
195,000 
1 
195,000 
Data Collectors meals (breakfast, dinner)/15 days  
1 
500,000 
Community Health Workers airtime   
1 
150,000 
Incentives for Study participants  
150 
120 
180,000 
Equipments for anthropometric measures  
- 
- 
45,000 
Miscellaneous (printing/photocopying,..) 
- 
- 
140,000 
Data entry and analysis In kind  
- 
- 
0 
Total Budget for Phase One 
2,060,000 
Post PDC Phase Two 
Activity                                
Unit Cost 
(RWF) 
 Unit Number    
Total cost 
(RWF) 
RNEC Application  
425,000 
1 
425,000 
Data entry In kind  
- 
- 
0 
Data analysis In kind  
- 
- 
0 
Paper submission fee  
72,000 
1 
72,000 
Total Budget for Phase Two 
497,000 
Total Budget for PDC Study (Phases One and Two) 
2,557,000 
 
Expanding-PDC Phase Three 
Activity                                
Unit Cost 
(RWF) 
Unit Number 
Total cost 
(RWF) 
RNEC Application  
425,000 
1 
425,000 
Data entry/collection 
340,972 
24 
8,183,320 
Data analysis  
112,575 
24 
2,701,809 
Total Budget for Phase Three 
11,310,129 
Total Budget for PDC Study (Phases One, Two, and 
Three) 
15,927,120 
 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
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Acronyms 
 
1. ASQ: Ages and Stages Questionnaire 
2. BCH: Boston Children’s Hospital 
3. BWH: Brigham and Women’s Hospital 
4. FSI: Family Strengthening Intervention 
5. IMB: Inshuti Mu Buzima 
6. IMBRC: Inshuti Mu Buzima Research Commitee 
7. IRB: Institutional Review Board 
8. MD: Medical Doctor 
9. MOH: Ministry of Health 
10. MS: Masters of Science 
11. NCD: Non Communicable Diseases 
12. NHRC: National Health Research Committee 
13. PIH: Partners In Health 
14. RNEC: Rwanda National Ethics Committee 
15. U.S: United States 
 
 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
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References 
 
Baker-Henningham, Helen, Lopez Boo, Florencia. Early Childhood Stimulation Interventions  
      in Developing Countries: A Comprehensive Literature Review, October 2010. 
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Ballot, DE, Potterton J, Chirwa T, Hilburn N, Cooper PA.  Developmental Outcome of Very   
       Low Birth Weight Infants in a Developing Country. BMC Pediatr. 2012 Feb 1;12:11.   
 
Biencowe, H. Lee, A, et al.  Preterm Birth-associated Neurodevelopmental Impairment  
       Estimates at Regional and Global Levels for 2010.  Pediatr Res. 2013 Dec;74 Suppl 1:17-34. 
 
Childers DO, LaRosa AC. Early Intervention. Developmental and Behavioral    
      Pediatrics.  American Academy of Pediatrics, 2011: 59-68. 
 
Ertem IO, Dogan DG, Gok CG, et al. A Guide for Monitoring Child Development in  
      Low- and Middle-Income Countries. Pediatrics. 2008 Mar;121(3):e581-9. 
 
Feldman, Ruth. Eidelman, Arthur I.  Neonatal State Organization, Neuromaturation, Mother- 
       Infant Interaction, and Cognitive Development in Small-for-Gestational-Age Premature  
       Infants.  Pediatrics September 2006; 118:3 e869-e878. 
 
Grantham-McGregor et al. Developmental Potential in the First 5 years for Children in  
        Developing Countries. Lancet. 2007 Jan 6;369(9555):60-70.  
 
Nordhov, Marianne S., Ronning, John A. et al.  Early Intervention Improves Cognitive  
      Outcomes for Preterm Infants: Randomized Controlled Trial.  Pediatrics 2010; 126:5    
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Nordhov, Marianne S., Ronning, John A. et al.  Early Intervention Improves Behavioral  

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     Outcomes for Preterm Infants: Randomized Controlled Trial.  Pediatrics 2012; 129:1    
       e9-e16. 
 
McGowan JE, Alderdice FA, Holmes VA, Johnston L. Early Childhood Development of Late- 
      Preterm Infants: A Systematic Review. Pediatrics. 2011;127(6):1111–1124 
 
McManus BM, Carle AC, Poehlmann J. Effectiveness of Part C Early Intervention    
     Physical, Occupational, and Speech Therapy Services for Preterm or Low Birth Weight  
     Infants in Wisconsin, United States.  Acad Pediatr. 2012 Mar-Apr;12(2):96-103.  
 
 Rwanda Health Statistics Booklet 2012.  
     Sources of Data: National Health Management Information System database 2010 and 2011 
 
Rwanda Ministry of Health. 2010. Rwanda Demographic and Health Survey.  
     Retrieved from: http://www.measuredhs.com/pubs/pdf/PR7/PR7.pdf.  
 
Sices L, Developmental Screening in Primary Care: The Effectiveness of Current   
     Practice and Recommendations for Improvement. The Common Wealth Fund, Dec 2007 
 
World Health Organization. 2012. Early Childhood Development and Disability: A  
     discussion paper.  
     Retrieved from:   www.who.int/disabilities/publications/other/ECDD_final_word.doc.  
 
 
 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
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Appendix A: Household Data Collection Tools 
 
Previously Approved tools include: 
 Informed Consent form for study Aim 4 
 Early Childhood Development Survey for study Aim 4 
 
New tools include: 
 Informed consent form for study Aim 5  
 Developmental screening tools for study Aim 5 
 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
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Appendix B: New Tools Phase 3 
 
New tools include: 
 New/revised medical record forms for the PDC 
 Neonatal Unit Register 
 Breastfeeding quality improvement project data tracker 
 Guide for Monitoring Child Development 
 Qualitative interview guides and consents 
 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
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Appendix C: CVs of New Investigators 
 
 Alphonse Nshimyiryo, Partners In Heatlh 
 Chiquita Palha de Sousa, MD, Boston Children’s Hospital Global Pediatrics Fellow 
 Ryan McBain, ScD, Partners In Health 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
40 
 
Appendix D: Prior RNEC Approvals 
 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
41 
 
Appendix E: Payment Receipt for August RNEC Review 
 

Approved by Rwanda National Ethics Committee, 9 September 2017 
42 
 
Appendix F: Previously Approved Study Tools 
 
Previously approved study tools that are still in use in the PDC program are included here. These 
include routine Pediatric Development Clinic Medical Record forms, a mentorship checklist, and 
the Ages and Stages Questionnaires administered starting at age 6 months in the clinic.