A study to see if cooling babies with birth asphyxia is beneficial
Phase 2
Completed
- Conditions
- Health Condition 1: null- Neonates with hypoxic ischemic encephalopathy
- Registration Number
- CTRI/2013/05/003693
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
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 5â??
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)
Exclusion Criteria
1. Lack of consent
2. Major congenital malformations
3. Imminent death anticipated at the time of assessment for eligibility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method