This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.
Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia
Hypothermia treatment for 72 hours
Parental consent form
Congenital malformation
Concurrent cerebral lesions
ECMO therapy
Contraindication of lactation
Parallel
Intranasal breast milk
Biological/VaccineOwn-mother's fresh breast milk (within 4 hours of having been expressed), is administered intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril.
Neurodevelopmental outcome
The primary outcome will be the 2 year neurodevelopmental outcome comparing standard care and intranasal breast milk therapy groups. The Bayley Scales of Infant Development, Third Edition (Bayley-III) score will be used to assess neurodevelopmental outcome, favorable outcome is defined as having composite scores for cognitive, language and motor scales \>85, while adverse outcome is defined as composite scores \<80 or death.
Time to reach full enteral feeding
Time to reach full enteral feeding will be recorded and analyzed as a secondary outcome.
Length of exclusive breast feeding
Lengths of exclusive breast feeding will be recorded and analyzed as a secondary outcome.
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