Intranasal Breast Milk Therapy in HIE
Recruiting now · Early Phase 1
Conditions studied: Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Perinatal Asphyxia, Neonatal Hypoxic Ischemic Encephalopathy
In brief
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.
Key facts
- Study ID
- NCT06746532
- Run by
- Semmelweis University
- People needed
- 80
- Starts
- 2025-02-01
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2024-12-24
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia
- ≥ 35. gestational week < 48 hours of life
- Hypothermia treatment for 72 hours
- Parental consent form
You may not qualify if…
- Congenital malformation
- Concurrent cerebral lesions
- ECMO therapy
- Contraindication of lactation
- Mother unable or unwilling to provide fresh breast milk
- Postpartum asphyxia
Where it is running
- Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary — Budapest, Hungary (enrolling)
Full record on ClinicalTrials.gov
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