Health Condition 1: P969- Condition originating in the perinatal period, unspecified
Conditions
Interventions
Intervention1: Intranasal application of human milk: Fresh human milk will be instilled into each nostril every 6 hours, using a one ml syringe, starting within 5 days of age
Control Intervention1: Us
Sponsors
Banaras Hindu University
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Chromosomal anomalies 2. Major congenital malformation 3. Microcephaly 4. Dysmorphic features 5. Suspected intrauterine infection 6.Failure to obtain consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain MRI changesTimepoint: 4 weeks of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neurodevelopmental assessment at age of 6 ±1 months. 2. Brain MRI findings at age of 6 ±1 months 3. Hospital mortality 4. Late onset sepsis after randomization 5. Length of hospital stay 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. 7. Motherâ??s response & acceptance to intranasal human milk application Timepoint: 6 months of age | — |
Countries
India
Contacts
Public ContactAnkita Pakhale
Banaras Hindu University
Outcome results
None listed