Actively Recruiting
Feasibility and Safety of Intranasally Administered Breast Milk in HIE
Led by Semmelweis University · Updated on 2025-05-22
10
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility and Safety of Intranasally Administered Breast Milk in HIE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Congenital malformation
- Concurrent cerebral lesions
- ECMO therapy
- Contraindication of lactation
- Mother unable or unwilling to provide fresh breast milk
- Postpartum asphyxia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Division of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary
Budapest, Hungary, 1083
Actively Recruiting
Research Team
U
Unoke Meder, MD, PhD
CONTACT
A
Agnes Jermendy, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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