A study of whole body cooling and brain injury markers in babies with birth asphyxia
- Conditions
- Health Condition 1: null- Babies with perinatal asphyxia (hypoxic ischemic encephalopathy stage 2 and 3)
- Registration Number
- CTRI/2018/01/011085
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 154
1. Gestational age greater than or equal to 37 weeks
2. ABG(umbilical cord or 1st postnatal hour) pH less than or equal to 7 or BE greater than or equal to -12
3. Evidence of encephalopathy (Sarnatâ??s staging 2 or 3)
4. Any two of the following
i. APGAR less than or equal to 6 at 5 min
ii. Evidence of fetal distress
iii. Assisted ventilation for at least 10 min after birth
iv. Evidence of any organ dysfunction
v. History of acute perinatal event- intrapartum fetal distress, cord prolapse placental abruption, uterine rupture, maternal trauma, cardiac arrest
1. . Infants more than 6 hours of age at the time of randomization
2. Major congenital abnormalities
3. If the baby does not establish spontaneous respiration by 20 minutes
4. Out born babies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method