Actively Recruiting
Intranasal Breast Milk Therapy in HIE
Led by Semmelweis University · Updated on 2024-12-24
80
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intranasal Breast Milk Therapy in HIE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate or severe hypoxic-ischemic encephalopathy receiving therapeutic hypothermia
- Gestational age of at least 35 weeks
- Less than 48 hours old at enrollment
- Receiving hypothermia treatment for 72 hours
- Parental consent obtained
You will not qualify if you...
- Presence of congenital malformations
- Concurrent cerebral lesions
- Receiving ECMO therapy
- Contraindications to 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
Department 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
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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