Evaluating the Accuracy of a Neonatal Temperature Monitor in Comparison With Existing Temperature Monitors
Phase: NA
Conditions: Neonatal Hypothermia
Sponsor: William Marsh Rice University

 
 
 
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A. Title 
 
Assessment of low-cost temperature monitoring tools for neonates.  
B. Investigators  
 
Principal Investigator: 
 
Dr. Queen Dube, College of Medicine, Blantyre, 
Malawi  
 
Co-Investigators: 
Rebecca Richards-Kortum, PhD, Dept. of Bioengineering, 
Rice University, Houston, TX USA 
Maria Oden, PhD, Dept. of Bioengineering, Rice University, 
Houston, TX, USA 
Megan Heenan, Rice 360: Institute for Global Health, Rice 
University, Houston TX, USA  
Mary Kate Hardy, Rice 360: Institute for Global Health, Rice 
University, Houston TX, USA  
Prince Mtenthaonga, Rice 360: Institute for Global Health 
 
 
Investigators’ CVs:  
Please see Appendix 1 
 
C. Institutions under whose umbrella the research project will be conducted 
 
[i]  College of Medicine, Blantyre, Malawi 
[ii] Rice University, Houston, TX, USA 
 
D. Executive summary 
 
Problem statement: Neonatal hypothermia is a pervasive global challenge; as many as 
85% of infants born in hospitals in low-resource settings are too cold (defined as a 
temperature <36.5C) [1].  A recent study of 23,240 newborns in Nepal showed that 
babies with moderate hypothermia are nearly five times more likely to die than 
normothermic infants; the risk of death is more than 23 times higher for babies with 
severe hypothermia [2].  While the risks of being too cold are well recognized, 
hypothermia remains a largely invisible problem in overcrowded newborn units in low-
resource settings.  Electronic temperature monitors used in high resource settings are not 
available in low-resource settings because they are too costly or require a constant 
supply of consumable thermistors. Simple digital or analog thermometers are often 
unavailable; when they are available, wards are often too short-staffed to permit routine 
monitoring at regular intervals.   
 
Aim of Study: A team of researchers at Rice University and QECH are working to 
develop a low-cost temperature sensor that can continuously monitor an infant’s 
temperature (NTM).  This robust, low-cost device will allow for the individualized 
monitoring of each infant with alerts for hypo and hyperthermia.  A reusable band to 

 
 
 
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hold the temperature sensor will eliminate disposable components.  This study will 
assess the accuracy of this novel device against a gold standard along with existing low 
cost temperature monitors, ThermoSpot and Bempu, to determine which tool is most 
accurate and effective for neonatal wards. 
 
Specific objectives: In this study, we intend to evaluate the accuracy of these devices 
at Queen Elizabeth Central Hospital (QECH) by comparing the temperature readings to 
a commercially available gold standard device.  We also want to ensure the devices are 
easy to understand and use and could be implemented in the wards. 
 
The specific objectives are: 
 
1. To determine the accuracy of the NTM, Bempu, and ThermoSpot devices 
when used by nurses in the neonatal ward by comparing 
a. Continuous temperature measurements 
b. Periodic temperature measurements 
c. Temperature during alarm events 
2. To ensure the NTM is easy to understand and use in the 
a. Nursery with open cots, hot cots, and radiant warmers 
b. KMC ward 
 
Methodology: This is a method comparison study taking place in the neonatal ward 
(Chatinkha) and KMC ward at Queen Elizabeth Central Hospital (QECH). Up to 60 
infants in need of temperature monitoring or thermal care will be enrolled in the study. 
The infants will be continuously monitored using the NTM, Bempu, ThermoSpot, and a 
gold standard temperature monitor for up to 3 days. The accuracy of the devices will be 
determined by calculating the difference between the temperatures recorded by the test 
devices and the commercial patient monitor at each point in time.  Our target error is 
less than +/- 0.5 C. 
 
Implications of the study and dissemination plans: The data collected here will be 
used to evaluate the use of the temperature monitoring devices as tools for monitoring 
and diagnosing hypothermia.  The results of this study will be made available to our 
partners working in neontal and child health.  Findings will be published in academic 
journals and conference proceedings in an effort to disseminate results to potential end-
users. 
 
E. Background Information and Introduction 
Neonatal hypothermia is a pervasive global challenge; as many as 85% of infants born in 
hospitals in low-resource settings are too cold (defined as a temperature <36.5C) [1].  A 
recent study of 23,240 newborns in Nepal showed that babies with moderate hypothermia 
are nearly five times more likely to die than normothermic infants; the risk of death is 
more than 23 times higher for babies with severe hypothermia [2].   
While the risks of being too cold are well recognized, hypothermia remains a largely 
invisible problem in overcrowded newborn units in low-resource settings.  Data show that 

 
 
 
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babies who suffer from even mild hypothermia are at increased risk of jaundice, sepsis, 
hypoglycemia [3], and death [2]; unfortunately, there are no visible signs of mild 
hypothermia and risks become significant long before a baby begins to feel cold to the 
touch. Hyperthermia is equally devastating- and sometimes can be caused by attempts to 
warm a baby without monitoring her temperature carefully. Additionally, large swings in 
temperature–known as thermal shock–can lead to negative outcomes, including death. 
Constant maintenance of infant temperature within a very tight range is therefore 
imperative [4]. Electronic temperature monitors used in high resource settings are not 
available in low-resource settings because they are too costly or require a constant 
supply of consumable thermistors. Simple digital or analog thermometers are often 
unavailable; when they are available, wards are often too short-staffed to permit routine 
monitoring at regular intervals.   
 
Although temperature monitoring is both a critical component of neonatal care and also a 
well-documented challenge, there is no broad consensus on the best method to monitor 
temperature in low-resource settings. We have developed a new device called NTM: a 
simple, affordable ($10), and rugged tool to continuously monitor and display 
neonatal temperature, providing a rapid way to alert clinical staff and mothers to 
periods of hypo- or hyperthermia. As shown in Table 1, NTM is a reusable temperature 
sensor attached to an infant’s abdomen to detect core body temperature.  It consists of a 
stretchy ‘”belt” that wraps around the abdomen of the infant and senses temperature 
through a small stainless steel sensor.  The belt and sensor can be easily cleaned 
between uses.   
 
Even mild hypothermia (temperature of 36-36.5 o C) is associated with a 1.8 fold increase 
in risk of mortality [2], thus our target accuracy for temperature monitoring is ± 0.5oC.  We 
have shown that NTM meets this standard in two settings through two IRB-approved 
studies conducted in Houston, TX.  First, we evaluated NTM’s accuracy compared to a 
Phillips Intellivue patient monitor temperature probe in healthy adults; results show 
temperatures measured with NTM are within 0.3oC compared to the gold standard. A 
similar evaluation of NTM monitoring infants in a daycare (subjects <18 months) showed 
that results within 0.5 oC of the gold standard.  
 
The user interface of the device was designed with feedback from Malawian doctors and 
nurses.  The baby’s temperature is displayed continuously on the battery powered control 
box; if the infant’s temperature drops below 36.5 oC, a blue light atop the box flashes to 
signal that intervention is necessary.  Similarly, if the infant’s temperature exceeds 37.5 
oC, a red light flashes signaling for intervention. The light flashes speed up with degree of 
hypo- or hyperthermia. 
 
NTM has important advantages compared to two other approaches which have been 
developed to address this need (Table 1). Unlike Bempu, a wrist-worn monitor that 
provides an audible alarm, NTM is placed over the liver to measure core temperatue and 
it displays temperature continuously. Neonatal nurses on our development team identified  

 
 
 
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continuous 
display 
of 
temperature as one of 
the most highly desired 
features of NTM because 
it would help improve the 
care they can provide 
while 
reducing 
their 
workload.  Thermospot, 
a temperature sensitive 
sticker, 
is 
another 
alternative 
to 
monitor 
neonatal 
temperature. 
While 
Thermospot 
changes color to indicate 
temperature 
(green 
at 
temperatures above 36.5oC, brown between 35.5 and 36.4oC, and black below 35.5oC) it 
is not reusable and the color change can go unnoticed without scheduled monitoring. 
 
In this study we plan to evaluate the ability of NTM, Bempu, and ThermoSpot to detect 
hypo- and hyperthermia in neonates by comparing to a gold standard electronic 
temperature monitor used in high-resource settings.   
 
 
F. Rationale/Justification for the research project 
 
Together, prematurity and infection account for more than 50% of neonatal mortality 
globally, resulting in a combined 1.7 million deaths each year [5].  Improved ability to 
monitor neonatal temperature could help improve outcomes for both preterm babies, who 
are at high risk of hypothermia, as well as babies with infections, who are at high risk of 
hyperthermia. In many low-resource settings, routine monitoring is simply not possible 
due to staff and equipment shortages.  Our innovation, NTM, offers an affordable, rugged, 
low-power tool that provides constant monitoring with digital display of temperature and a 
simple light to notify a guardian or nurse when intervention is necessary.  Furthermore, 
NTM is reusable, requires no consumables, and has a very simple design to facilitate 
easy maintenance and repairs.   
This study is the first step in a systematic evaluation of NTM in comparison to the gold 
standard of electronic monitors used in high resource settings as well as two other 
alternatives specifically designed for low-resource settings: Thermospot and Bempu.  
Both are easy to use and can diagnose need for thermal care at a glance. Thermospot is 
a low-cost, one-time use disposable system that requires no power. Bempu is a $30 
temperature monitoring bracelet that can run continuously for 30 days at which time it is 
replaced.  A careful evaluation and comparison of these three solutions will provide 
critical data to support improved access to continuous temperature monitoring in low-
resource settings.  Future studies may evaluate not only the accuracy of these tools, but 
how they affect nurse/caregiver behavior and influence patient outcomes. 
 
Table 1: Options for low cost neonatal temperature monitoring 
 
NTM 
Bempu 
ThermoSpot 
 
 
   
 
   
Benefits Easy to understand 
continuous visual cues 
and digital temperature 
display, no disposables 
Audiovisual 
alarm, intuitive, 
also suitable 
for in home 
use 
Visual cue for 
different levels of 
hypothermia, low 
cost, no power 
required 
Cost 
$10 
$30 (2000 Rs) 
Bempu.com 
$0.50 
Maternova.net 

 
 
 
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G. Objectives of the study 
 
[i] Broad  
 
The purpose of this study is to determine if three low-cost temperature monitoring 
devices can: 1) accurately measure neonatal temperature in a low-resource clinical 
setting, and 2) serve as an easy to use tool for monitoring temperature in low-resource 
settings. 
 
[ii] Specific 
 
The specific objectives for the current stage of this project are: 
1. To determine the accuracy of the NTM, Bempu, and ThermoSpot devices 
when used by nurses in the neonatal ward by comparing 
a. Continuous temperature measurements 
b. Periodic temperature measurements 
c. Temperature during alarm events 
2. To ensure the NTM is easy to understand and use in the 
a. Nursery with open cots, hot cots, and radiant warmers 
b. KMC ward 
 
  
H. Methodology  
 
[i] Study Type 
 
This is a pilot comparative study to determine the level of agreement between three 
low cost temperature monitors against a continuous commercially available gold 
standard.  The accuracy will be assessed both on infants in the neonatal ward as well 
as infants undergoing Kangaroo Mother Care (KMC).   
 
[ii] Place of Study  
 
This clinical study will take place at Queen Elizabeth Central Hospital (QECH) in 
Blantyre, Malawi. Patients will be recruited as they are admitted to the neonatal or KMC 
wards.  
 
[iii] Study Population  
 
Subjects will be drawn from the population of infants being treated at QECH. 
 
[iv] Study Period 
 
We anticipate the study will take 2-3 months.  
 
 
 

 
 
 
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[v] Sample Size 
 
This study will enroll up to 60 infants at Queen Elizabeth Central Hospital. Up to 30 
subjects will be collected from the neonatal ward and 30 subjects from the KMC ward.   
This sample size will ensure that we are able to collect sufficient data from infants with a 
range of gestational ages, weights, temperatures, and treatment locations (ie open cot, 
radiant warmer).  The data from this study can be used to calculate the sample size 
needed in a larger study to evaluate changes in outcomes and nurse behavior related to 
the different temperature monitors. 
 
Inclusion criteria:  
 
1. The subject is currently being treated at QECH in the neonatal or KMC ward. 
2. Study devices are available for use. 
3. The subject’s caregiver has provided informed consent for their child to participate. 
 
The subject may be excluded from the study at the clinician’s discretion for any reason 
including potential for skin irritation, cough or other condition that may preclude use of 
the temperature belt, or concurrent treatments that may require increased patient care.   
 
If a patient is not enrolled in the study, the patient will receive the standard of care. 
 
Informed Consent: 
 
The investigator will provide details of the study to all eligible subjects’ guardian and 
answer all questions. Fully informed and signed consents will be obtained from the 
subject’s guardian prior to the start of any study procedures. 
 
Documentation of the consent process will include the following elements: 
 
• Date and time of consent; 
 
• Topics discussed with the subject’s guardian (e.g. risk, benefits, etc.); and 
 
• Confirmation that the consent was reviewed, that the guardian’s questions were 
answered, and that a signed copy of the consent was provided to the subject’s 
guardian. 
 
Potential Benefits and Compensation of the Proposed Research to Human Subjects 
and Others:  Neonates and infants at risk for hypothermia may benefit from participating 
in this study as alternative forms of accurate and frequent monitoring may not be readily 
available. This study may benefit infants in the future as the accuracy and usability of 
the test devices can be used to improve access to temperature monitoring equipment in 
the future.   
 
 

 
 
 
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[vi] Data Collection 
 
Training: 
 
1. Prior to the start of the study, all study nurses/clinicians will receive training on how 
to use the test devices.  Clinical decisions will still be based on the standard of care, 
which will not be interrupted during the study.  The study nurse/clinician will apply 
the temperature sensors to the infant. 
2. A research technician will be available for the duration of the study to record the data 
from the monitors. 
 
Enrollment : 
 
Enrollment will take place after fully informed and written consent from the parent or 
guardian. A parent will be free to withdraw their child from participating at any time, 
without explanation and without detriment to ongoing care.  There will be no financial 
benefit to participants though the infants will benefit from close monitoring.   A 
participant identification number will be assigned. This number will be used for 
identification purposes throughout the study. 
 
Monitoring of Neonates: 
 
During the trial, the following steps will be taken: 
 
A trained study nurse will assess the subject for clinical complications before attaching 
the temperature monitoring device.  
 
1) A trained study nurse or clinician will attach the three test temperature monitoring 
devices to the infant. A trained research assistant from Rice University or from the 
Biomedical Engineering Department at Malawi Polytechnic will observe all 
procedures and will notify the nurse of any observed errors so they may be 
corrected. They will also be able to answer any technical questions from the nurse. 
2) The trained study nurse will attach the temperature probe from the commercial gold 
standard as well as provide any other care needed. 
3) A research assistant will use a laptop to collect data from the continuous 
temperature monitors (NTM and gold standard).   The nurse will record the 
temperature readings every hour from all monitors on paper forms along with the 
standard of care. 
4) Each time an alarm sounds from any device (Bempu and the commercial gold 
standard have audible alarms), the nurse will record all temperature values including 
a reading taken with the standard of care method.  If the subject is found to be 
hyper/hypothermic, the nurse will respond with the appropriate standard of care. 
5) Temperature monitoring will continue for up to 3 days.  The research assistant may 
ask the nurse to remove and reapply the temperature probes during this period. 
 

 
 
 
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A research assistant will be available during the trial to mitigate any complications with 
the devices. If the subject’s guardian, the nurse, or the research assistant indicates 
concern during the tests, temperature monitoring will be discontinued and the subject’s 
treatment will return to the standard of care.  The nurse can choose to remove one of 
the test devices and continue the study with the remaining monitors if any issue arises. 
 
Clinical data will be collected on paper forms as is consistent with current clinical 
practice. Data from the temperature monitors will be saved on a secure study server for 
analysis. Clinical and/or research personnel will record information, excluding personal 
identifiers, on a standardized patient monitoring form. After the subject’s participation is 
complete, a research assistant will collect and scan the form. 
 
The following section details the variables that will be measured or calculated in the 
study. 
 
Intended Data Collection:  
 
1. Baseline demographic and relevant medical information 
a. Recorded once at enrollment 
i. Date of Study 
ii. Date of Birth 
iii. Sex 
iv. Birth Weight  
v. Type of delivery 
vi. Gestational age at birth 
vii. Corrected gestational age  
viii. Abdominal circumference 
ix. Admission Temperature 
b. Recorded throughout study as clinically collected 
i. Other comorbidities 
ii. Medications/treatments given 
iii. Current weight 
iv. Additional temperature measurements taken as standard of care 
 
2. Accuracy 
a. Recorded automatically by study equipment 
i. Abdominal 
temperature 
and 
alarms 
from 
Rice 
designed 
temperature monitor and gold standard device 
b. Recorded every hour by study nurse or as alarm events occur 
i. Temperature measurements from other devices 
ii. Temperature measurements using standard of care method 
(axillary) 
iii. Ambient temperature 
iv. Current thermal treatment, if any 
c. Movement/other caregiving 
d. Fit/tightness of the devices 

 
 
 
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A log of observed user error and comments may be used to improve the usability of the 
test devices. 
 
[vii] Data Management and Analysis 
Personal identifiers will be removed from the data which will be kept on a secure server 
accessible only to study personnel.   
 
The accuracy of the temperature sensors will be determined by calculating the 
difference between the temperatures recorded by the temperature sensor and the 
commercial patient monitor at each point in time.  The average error between the 
temperature sensor and the gold standard will be calculated for each subject and 
compiled in a Bland-Altman plot. The 95% limits of agreement will be calculated.  Our 
target error is less than +/- 0.5 C.   
 
For the devices that do not provide a continuous numerical reading, the recorded state 
every hour will be compared to the gold standard at that point in time.   The sensitivity 
and specificity for hypo/hyperthermia will be calculated for each device. 
 
The ability of each device to accurately diagnose hypothermia will also be calculated 
with respect to the alarm events for each device for which they were recorded.  The 
sensitivity and specificity will be determined using the number of false alarms collected 
during the study. 
 
As a secondary analysis, the errors will be plotted against thermal treatment type and 
ambient temperature to determine their confounding effects on accuracy.   An ANOVA 
will be used to determine statistical significance.   
 
The research team from Rice University and QECH will be responsible for all data 
analysis.  We plan to analyze data using Excel, MATLAB, and associated statistics 
packages.  
 
[viii] Results Presentation 
 
Statistical analysis will be performed and means, limits of agreement, sensitivities and 
specificities will be reported.  Tables and graphs may also be used to present any 
additional correlations, explain outliers, or demonstrate confounding effects.   
 
[ix] Dissemination of Results 
 
The results of this study will be made available to the Ministry of Health, COMREC, the 
College of Medicine Library, the Department of Paediatrics, and other partners working 
in neonatal and child health. A copy of the final report and any published papers or 
abstracts will be submitted to The Health Sciences Research Committee and the 
University Research and Publication Committee (URPC) through the COMREC 
Secretariat. Findings will be published in academic journals and conference 

 
 
 
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proceedings in an effort to disseminate results to potential end-users. The research 
findings of this study will be critical in the evaluation of future interventions. 
 
I. Ethical considerations 
 
The risks and discomfort associated with participating in this study are no greater than 
those associated with routine monitoring. No clinical decisions will be made on the basis 
of any test device. Infants will be removed from the study if study participation interferes 
with care. Infants at risk for hypothermia may benefit from close temperature monitoring 
provided by the test devices, commercial patient monitor, and dedicated study nurses.  
Others may benefit from this study in the future as this evaluation may help identify a 
low-cost, robust temperature monitor for low-resource hospitals. 
 
The study protocol will be approved by COMREC and the Institutional Review Board at 
Rice University prior to initiation of the study. All investigators will be required to take the 
online Protecting Human Research Participants course provided by the NIH Office of 
Extramural Research.  Any loss of patient data will be reported to the University of 
Malawi COMREC through the PI and to the Institutional Review Board at Rice 
University. Information will be de-identified to ensure patient confidentiality and data 
integrity.   
 
All studies involving human subjects will be conducted in a manner that will minimize 
the risk to the individual, utilize all patient materials for scientifically meaningful 
purposes, and protect individual rights to confidentiality. The associated clinical 
protocols will be approved by COMREC in Malawi and by the Institutional Review Board 
of Rice University, Houston, TX. All researchers will conform to the standards set forth 
by the National Institutes of Health regarding experiments involving human subjects.  
 
The co-investigators will take the following steps to protect the participant's identities 
during this study: (1) Each participant will be assigned a number; (2) The co-
investigators will record any data collected during the study with this number and not by 
name; (3) Any original data files, as well as the informed consent forms, will be stored in 
a locked cabinet in the PI’s office space. All data will be recorded in a password-
protected database. Only the investigators listed in this study will have access to the 
data, and if the data is published at any time in the future, it will be reported collectively 
with no reference to the subjects' identities. 
 
J. Possible Constraints 
 
The subject may be removed from the study at any time at the request of the parents or 
clinicians.  Axillary temperature measurements given as the standard of care will 
continue during the study and will not be interrupted.   
 
After each subject, the devices will be cleaned thoroughly with a bleach solution. 
 

 
 
 
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There is the potential risk of the loss of confidentiality associated with participation in 
this study. No patient identifiers will be collected by the study. All patient data will be 
assigned a number to ensure subject confidentiality. All efforts will be made to maintain 
strict patient confidentiality.  
 
K. Study Requirements 
 
The study will require the following:  
 
Personnel: 
Dr. Queen Dube, College of Medicine, Blantyre, Malawi: Principal Investigator 
Research technician: A researcher from Rice University will travel to Blantyre 
(supported by Rice University).  
Study nurse: Prince Mtenthaonga 
 
Training:  
Prior to the start of the study, all study nurses/clinicians will receive training on the use 
of the test devices by the Rice research team. Each member will pass a standard 
evaluation in order to operate the device. The Rice researcher and Dr. Dube will be 
available on site or by phone, email, and site visits to respond to any questions and/or 
concerns. The US- based investigators will be in frequent contact with the local team. 
 
Paper: The Rice researcher will provide all consent and monitoring forms.  
 
Equipment: The temperature monitoring devices will be provided by Rice for the study. 
 
No transport, reagents, drugs or additional space will be required for the study.  
 
L. Budget and budget justification 
 
Salary Description 
Cost 
Queen Dube Honorarium  
$1500 
Study Nurse 
$600 
Printing Costs 
$150 
Direct Costs Total 
$2250 
10% F&A Costs 
$225 
Total 
$2475 
 
The test devices and paper forms (consents and monitoring forms) will be provided by 
Rice University.  We have received funding from private donors to support this study. 
 
This study is part of a larger plan to investigate and implement low cost temperature 
monitoring tools in neonatal wards.  We estimate that this study comprises 30% of that 
work, for which an honorarium of $5000 was assigned.  Therefore, we have listed the 
appropriate proportion of that honorarium here. 
 

 
 
 
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N. References 
 
1. Lunze et al. J Perinatol. 2012 May;32(5):317-24. 
2. Mullany et al Arch Pediatr Adolesc Med. 2010;164(7):650-656.  
3. Waldron et al. Infant Journal. 2007 May; 3(3). 
4. Amadi, et al. Paediatrics and international child health 2015:35(3). 
5. "Preterm Birth." World Health Organization. Nov. 2015. Web. 04 Oct. 2016.