Feasibility and Safety of Intranasally Administered Breast Milk in HIE
Recruiting
Early Phase 1
Interventional Study
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
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
- 10 (estimated)
- Sponsor
- Semmelweis University · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* Congenital malformation
* Concurrent cerebral lesions
* E…
Contacts