acetylcysteine to improve neurological outcomes in neonates with hypoxic ischemic encephalopathy
- Conditions
- Health Condition 1: P039- Newborn affected by complication of labor and delivery, unspecified
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion criteria (The baby should meet criteria from either A or B, plus the criteria in C)
1. Inborn babies with gestational age >= 36 weeks with ABG (umbilical cord or 1st postnatal hour) pH <=7 or Base deficit >= 12 meq/L
2. Any one of the below mentioned criteria
i. APGAR <=5 at 10 min
ii. Assisted ventilation for at least 10 min after birth
iii. History of acute perinatal event- intrapartum fetal distress, cord prolapse, placental abruption, maternal trauma, uterine rupture, cardiac arrest
3. Presence of moderate or severe encephalopathy by clinical examination (Modified Sarnat staging).
Exclusion criteria
1) Infants >6 hours of age at the time of randomization.
2) Major congenital abnormalities.
3) Babies who do not have spontaneous respiration at 20 minutes of life
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite outcome of death or abnormal neurodevelopment at 6 months of age.Timepoint: Six months corrected age
- Secondary Outcome Measures
Name Time Method