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Intranasal Breast Milk Therapy in HIE

RecruitingEARLY Phase 1Ages any - 48 HoursAllSemmelweis University
NCT06746532 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Intranasal breast milk
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Where

1 site
Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary
Budapest, Hungary
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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