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Intranasal Breast Milk Therapy in HIE
Sponsor: Semmelweis University
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.
Official title: Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)
Key Details
Gender
All
Age Range
Any - 48 Hours
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-02-01
Completion Date
2030-12
Last Updated
2024-12-24
Healthy Volunteers
No
Conditions
Interventions
Intranasal 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