Feasibility and Safety of Intranasally Administered Breast Milk in HIE
Recruiting now · Early Phase 1
Conditions studied: Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy, Brain Injury, Perinatal Asphyxia, Perinatal Asphyxia , Moderate to Severe HIE
In brief
This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
Key facts
- Study ID
- NCT06747260
- Run by
- Semmelweis University
- People needed
- 10
- Starts
- 2024-11-22
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2025-05-22
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Moderate or severe hypoxic- ischaemic 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
- Division of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary — Budapest, Hungary (enrolling)
Full record on ClinicalTrials.gov
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