| CTRI Number |
CTRI/2013/05/003693 [Registered on: 29/05/2013] Trial Registered Prospectively |
| Last Modified On: |
03/01/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [non drug intervention- therapeutic hypothermia] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see if cooling babies with birth asphyxia is beneficial |
|
Scientific Title of Study
|
A randomized controlled trial of therapeutic hypothermia for neonatal hypoxic-ischemic encephalopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niranjan Thomas |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Neonatology
Christian Medical College
Vellore
Ida Scudder Road
Vellore
Tamilnadu
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283311 |
| Fax |
|
| Email |
niranjan@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niranjan Thomas |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Neonatology
Christian Medical College
Vellore
Ida Scudder Road
Vellore
Tamilnadu
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283311 |
| Fax |
|
| Email |
niranjan@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niranjan Thomas |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Neonatology
Christian Medical College
Vellore
Ida Scudder Road
Vellore
Tamilnadu
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283311 |
| Fax |
|
| Email |
niranjan@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Central Norway Regional Health Authority (RHA) and the Norwegian Universityof
Science and Technology (NTNU)."
|
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Ida Scudder Road
Vellore
Tamilnadu 632004 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| St Olavs University hospital Trondheim Norway |
St. Olavs University hospital, Trondheim, Norway. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Niranjan Thomas |
Department of Neonatology |
Christian Medical College
Vellore
Vellore
TAMIL NADU |
041622
niranjan@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB, Chrisitian Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neonates with hypoxic ischemic encephalopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard care |
standard care for perinatal asphyxia which will include iv fluids, anticonvulsants and supportive care as per current protocol |
| Intervention |
Therapeutic hypothermia |
Babies who fulfill the inclusion criteria will be cooled using phase changing mattress to a target temperature of 33.5 C (33 to 34 C). This will be maintained for 72 ours after which they will be re-warmed at 0.2 C per hour till they reach normothermia (36.5 C). |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
1. Age of newborn : <6 hours of age
2. GA >35 wks and Birth weight > 1800 g
3. PHYSIOLOGICAL CRITERIA- Any 1 of the following
ï® ABG (Umbilical cord / 1st postnatal hr) pH < 7.0 or base deficit > - 12
ï® Apgar score < 5 at 5’
ï® Ventilation required for at least 10 minutes as part of resuscitation at birth
4. NEUROLOGICAL CRITERIA- Seizures (OR) Evidence of moderate or severe encephalopathy (3 of 6 criteria in modified Sarnat)
|
|
| ExclusionCriteria |
| Details |
1. Lack of consent
2. Major congenital malformations
3. Imminent death anticipated at the time of assessment for eligibility
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MRI abnormalities at 5 ±1 days of life |
MRI abnormalities at 5 ±1 days of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Chorioamnionitis-placental histology & IL6 levels
Amiel-Tison
General movement assessment
Death or neurodevelopmental impairment at 18 months |
Short term (before discharge from hospital)&/or at 7 days
Intermediate term (10-15 weeks)
Long term: 18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/06/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study, babies
admitted to the NICU before 6 hours of life will be included according to
specified criteria including biochemical, physiological and clinical parameters
supporting a diagnosis of birth asphyxia.
Infants will be randomized to standard care as per nursery protocol or standard
care plus 72 hours of hypothermia induced by a Phase-Changing Material (PCM)
mattress. Infants will be assessed with cerebral MRI at 5 days of
age, a standardized neurological assessment (AmielTison) at 7 days of age,
General Movements assessment (GMA) and computer-based infant movement
assessment (CIMA) at 10-15 weeks and neurodevelopmental assessment at 24
months. The persons performing and interpreting the outome
(MRI, GMA/CIMA and neurodevelopmental outcome) will be blinded to the randomisation. Primary outcome will be MRI abnormalities at 5 days.
Secondary outcomes will be neurological status at discharge, General Movements
assessment (GMA) at 10-15 weeks and neurodevelopmental disability at 24
months. We will also look at the role of
perinatal infection in brain injury by looking at placental evidence of
chorioamnionitis and serial serum IL 6 levels. |