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CTRI Number  CTRI/2020/06/025902 [Registered on: 16/06/2020] Trial Registered Prospectively
Last Modified On: 07/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Therapeutic Hypothermia for birth Asphyxia using Revive servo-controlled device – a randomised controlled trial. 
Scientific Title of Study   Therapeutic hypothermia for birth Asphyxia using a new servo-controlled device – A randomised controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Guruprasad 
Designation  Professor and HOD 
Affiliation  J.J.M Medical College 
Address  Dept of Neonatology JJM Medical college, Davangere

Davanagere
KARNATAKA
577004
India 
Phone    
Fax    
Email  dr_g_gp@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G Guruprasad 
Designation  Professor and HOD 
Affiliation  J.J.M Medical College 
Address  Dept of Neonatology JJM Medical college, Davangere

Davanagere
KARNATAKA
577004
India 
Phone    
Fax    
Email  dr_g_gp@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr G Guruprasad 
Designation  Professor and HOD 
Affiliation  J.J.M Medical College 
Address  Dept of Neonatology JJM Medical college, Davangere

Davanagere
KARNATAKA
577004
India 
Phone    
Fax    
Email  dr_g_gp@yahoo.com  
 
Source of Monetary or Material Support  
Sensivision Health Technologies Pvt. Ltd. #164, 1st Cross, 1st Stage, AECS Layout, Sanjaynagar, RMV II Stage, Bengaluru 
 
Primary Sponsor  
Name  Sensivision Health Technologies Pvt Ltd 
Address  164, 1st Cross, 1st Stage, AECS Layout, Sanjaynagar, RMV II Stage, Bengaluru 
Type of Sponsor  Other [Private Limited Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Guruprasad  JJM Meedical College  Dept of Neonatology JJM Medical college, Davangere
Davanagere
KARNATAKA 		 9844065889

dr_g_gp@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, J.J.M Medical College  Approved 
SNMC-Institutional Ethics Committee of Human Subjects Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P916||Hypoxic ischemic encephalopathy [HIE],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Phase Change Material based non-servo device  Whole body cooling done with this will require constant monitoring of the core body temperature and making manual intervention to control the cooling, 
Intervention  Servo-controlled Whole Body Cooling   This device will automatically perform whole body cooling non-invasively by monitoring the core body temperature of the baby using rectal means. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  i. Inborn baby with GA ≥ 36 weeks and BW ≥ 2000 grams
ii. Age less than 6 hours
iii. Umbilical arterial (or gas within 1 hour of life) pH ≤7 or Base deficit ≥ 12 meq/L. If blood gas is unavailable, then any one of the following can be used
a) APGAR ≤ 5 at 10 min
b) Assisted ventilation for at least 10 min after birth
c) History of acute perinatal event- intrapartum fetal distress, cord prolapse, placental abruption, maternal trauma, uterine rupture, cardiac arrest
iv. Presence of moderate or severe encephalopathy by clinical examination (Modified Sarnat & Sarnat staging) consisting of:
a) Seizures b) Altered state of consciousness (reduced or absent response to stimulation) c) Abnormal tone (focal or general hypotonia, or flaccid) d) Abnormal primitive reflexes
(weak or absent suck or Moro response) 
 
ExclusionCriteria 
Details  1) Major congenital abnormalities
2) Babies who fail to establish spontaneous respiration at 20 minutes of life
3) Absent heart rate at 10 min of age despite adequate resuscitation
4) Risk of imminent death 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effective cooling time (increased cooling effectiveness through effectively maintaining the the rectal temperature within the target temperature range of 33°C to 34°C during the maintenance.)  Continuous rectal temperature monitoring until 90 hours of age, and then every 8 h for the first week after birth. 
 
Secondary Outcome  
Outcome  TimePoints 
- Time to induction of cooling
- Mortality from any cause before discharge from hospital
- Gastric bleeds
- Persistent hypotension
- Pulmonary haemorrhage
- Persistent pulmonary hypertension
- Bleeding diathesis requiring blood products
- Culture-proven early onset sepsis
- Necrotizing enterocolitis
- Cardiac arrhythmia requiring therapy
- Severe thrombocytopenia (25,000/mm3)
- Renal failure (anuria 48 h with azotemia)
- Subcutaneous fat necrosis 		 Before discharge from hospital 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The Newborns selected for this trial will be administered therapeutic hypothermia using the servo-controlled Revive device.The baby would be wrapped in the Baby wrap which will be connected to Revive. Once the cooling settings are selected by the Clinician and the treatment is initiated, the device will deliver the cooling for the selected hours and then automatically rewarm the baby back to normo-therm in the duration selected by the Clinician. A key factor determining the success of the treatment is the baby’s Core body temperature being maintained in the target range. Therefore the primary end point of this trial is to determine the effectiveness of cooling by the Revive device, measured by the percentage of time the cooling is maintained in the target range. This is compared with the standard of care followed in the trial sites.

 
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