Whole body cooling to reduce brain injury following birth asphyxia
Phase 3
- Conditions
- Health Condition 1: null- Neonatal Encephalopathy
- Registration Number
- CTRI/2016/01/006534
- Lead Sponsor
- Imperial college London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 408
Inclusion Criteria
Inclusion Criteria (ALL THE THREE BELOW)
1.Age < 6 hours, Birth-weight >1.8 kg, Gestation >36 weeks
2.Need for continued resuscitation at 5 minutes after birth and/or 5 minute Apgar score <6 (in babies born at hospital) or lack of cry by 5 minutes of age (for babies born at home)
3.Evidence of moderate or severe encephalopathy on clinical examination within 6 hours of age.
Exclusion Criteria
•Exclusion Criteria
1.Absent heart rate at 10 minute of age despite adequate resuscitation.
2.Major life threatening congenital malformation.
3.Migrant family or parents unable/unlikely to come back for follow up at 18 months.
4.Lack of parental consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death or moderate or severe neurodisability at 18 to 22 monthsTimepoint: 18 to 22 months
- Secondary Outcome Measures
Name Time Method Mortality <br/ ><br>Timepoint: 18 to 22 months;Severe Neuro disabilityTimepoint: 18 to 22 months