Role of antioxidants in newborns failing to initiate breathing at birth
Phase 3
Completed
- Conditions
- Health Condition 1: null- Birth asphyxia
- Registration Number
- CTRI/2013/02/003379
- Lead Sponsor
- Government Medical College Bhavnagar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 95
Inclusion Criteria
1.Newborns with Apgar score of <6 at 5 min admitted within 6 hours of birth.
2.Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia).
Exclusion Criteria
1. Newborn hospitalized in NICU after 6 hrs of birth
2. Gestational age <32 wks.
3. Lethal congenital anomaly
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of birth asphyxia, mortality and neurodevelopmental outcomeTimepoint: Neurodevelopmental outcome at 6 months of age
- Secondary Outcome Measures
Name Time Method Duration of hospitalisation and mechanical ventilation.Timepoint: At time of discharge or expiry.