Application of human milk into nose for brain protection in babies who fail to breathe at birth
Phase 2
- Conditions
- Health Condition 1: P969- Condition originating in the perinatal period, unspecified
- Registration Number
- CTRI/2023/08/056505
- Lead Sponsor
- Banaras Hindu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Term or post term neonates will be recruited to the trial if they meet both of the following two criteria of eligibility: first, a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home); and second, evidence of encephalopathy based on clinical examination using modified Sarnat staging
Exclusion Criteria
1. Chromosomal anomalies
2. Major congenital malformation
3. Microcephaly
4. Dysmorphic features
5. Suspected intrauterine infection
6.Failure to obtain consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brain MRI changesTimepoint: 4 weeks of age
- Secondary Outcome Measures
Name Time Method 1. Neurodevelopmental assessment at age of 6 ±1 months. <br/ ><br>2. Brain MRI findings at age of 6 ±1 months <br/ ><br>3. Hospital mortality <br/ ><br>4. Late onset sepsis after randomization <br/ ><br>5. Length of hospital stay <br/ ><br>6. Safety of intranasal breast milk application, as evidenced by fall in oxygen saturation of more than 10% from baseline, increase in oxygen requirement of more than 10 % from baseline, bradycardia (heart rate below 100 per minute), apnea or choking episode, change in color within 2 minutes of milk application, restlessness within 2 minutes of milk application, escalation of respiratory support. <br/ ><br>7. Motherâ??s response & acceptance to intranasal human milk application <br/ ><br>Timepoint: 6 months of age