Intranasal Breast Milk Therapy in HIE
Recruiting
Early Phase 1
Interventional Study
Hypoxic-Ischaemic Encephalopathy
Neonatal Encephalopathy
Perinatal Asphyxia
Neonatal Hypoxic Ischemic Encephalopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 48 Hours
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Semmelweis University · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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
* ECM…
Contacts