Feasibility and Safety of Intranasally Administered Breast Milk in HIE
Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy
Semmelweis University
10 participants
Nov 22, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Moderate or severe hypoxic- ischaemic 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
Neonates with hypoxic-ischemic encephalopathy receive their own-mother's fresh breast milk intranasally, starting from the first 48 hours of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril (15 minutes apart).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06747260