RecruitingEarly Phase 1NCT06746532

Intranasal Breast Milk Therapy in HIE

Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)

Sponsor

Semmelweis University

Enrollment

80 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Summary

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.

Eligibility

Max Age: 48 Hours

Inclusion Criteria4

Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia
≥ 35. gestational week < 48 hours of life
Hypothermia treatment for 72 hours
Parental consent form

Exclusion Criteria6

Congenital malformation
Concurrent cerebral lesions
ECMO therapy
Contraindication of lactation
Mother unable or unwilling to provide fresh breast milk
Postpartum asphyxia

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Interventions

BIOLOGICALIntranasal breast milk

Own-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.

Locations(1)

Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary

Budapest, Hungary

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NCT06746532