Remote Biomonitoring for Temperature Surveillance of Mothers and Newborns: Pre-clinical and Clinical Evaluation
Phase: NA
Conditions: Temperature Change, Body
Sponsor: St. John's Research Institute

PROTOCOL: Apr 2014 
 
Study Design: Phase I/II Clinical Trial (single arm) 
 
Study participants: postnatal mothers and early neonates 
Inclusion criteria 
Postnatal mothers 
Newborns with birth weight above 1.8 kg -- not sick and on full feeds 
 
Testing device – RBM device. This is a 
wearable  sensor tag  which  can  monitor  temperature  and  transmit  the  data wirelessly  using  Bluet
ooth  Low  Energy. 
The sensor tag operates off a CR2032 coin cell and  can  operate  for  1  year.  The  enclosure 
package takes into account design elements 
and  incorporates  hermetic  sealing,  no  sharp corners,  no  crevices  for  accumulation  of  bacteria/du
st  and  is  easily  sterilizable 
(technical details of preliminary pre-clinical testing are available at URL: 
http://chips.ece.iisc.ernet.in/images/2/25/BIODEVICES_2014_24.pdf).  
 
Fig 1. Neonate in ICU with temperature probe 
 
Fig 2. Neonate mannequin with RBM device  
 
Fig 3. Baby-friendly enclosure 
 
Fig 4. Disassembled prototype 
 

Fig 5. Top and bottom view of the sensor 
 
Fig 6. Vertical cross-sectional view of the 
enclosure 
 
A gateway  to  bridge  the  sensor  tag  and  the  cellular  infrastructure  is housed independently or 
within a cellphone. The cellphone will display the temperature reading from the RBM device. 
Location of device & probes 
The RBM device will be placed on the abdomen between the xiphisternum and the umbilicus. Both 
the other probes (radiant warmer and the multichannel) will be placed near the RBM device 
separately. 
Device adhesion 
The RBM device will be strapped onto the abdomen using a combination of cotton and micropore 
adhesive tape. 
 
Sample size and sampling technique 
25 mother-baby pairs 
250 readings (A sample size of about 250 readings will ensure a power of 80% to detect a 5% 
difference in measurements between devices with 95% confidence) 
[At least 5 readings from mother and 5 readings from a neonate] 
 
Pre-requisites for conduct of experiment 
Radiant warmer and multichannel probe – both to be examined and serviced by the biomedical 
engineering dept; calibration certificate to be obtained from the responsible external agency 
 
Testing comparisons 
RBM device vs Radiant warmer probe vs Multichannel probe vs manual thermometer 
 
Duration & frequency of sampling 
Initially, after strapping on all 3 probes – there will be a waiting period of 10 minutes for temperature 
stabilization. Then the experiment will be started. 
RBM device, multichannel probe & Radiant warmer probe  – will automatically obtain readings 
continuously (every few seconds) and readings will be taken every 5 minutes. 
 Manual thermometer readings will be taken every 15 minutes at the following 5 timings: 0, 15, 30, 45 
and 60 minutes 
 
Participant safety 
For newborns – when the temperature on the radiant warmer is beyond the normal range (36.5 to 37.5 
deg Celsius), routine appropriate care as per neonatology department protocols will take 
precedence over the conduct of the experiment 
 
 
 
 
 
 
 

     Fever  
        or   
     Malignant 
Hyperthermia 
   Hyperthermia
 
 
Normal range 
 
 
               32.0 
 
 
  36 
36.4 
 
  37.5 
 
 
40.0 
 
 
Severe  
        Hypothermia 
Hypothermia 
 
 
 
 
Grades of Hypothermia 
1 
36.0-36.4 (Cold stress)  
2 
35.0-35.9 
 
3 
34.0-34.9 
 
4 
32.0-33.9 
 
5 
<32.0