Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 2 days
Healthy Volunteers: f
View:
• Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia
• ≥ 35. gestational week \< 48 hours of life
• Hypothermia treatment for 72 hours
• Parental consent form
Locations
Other Locations
Hungary
Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary
RECRUITING
Budapest
Contact Information
Primary
Unoke Meder, MD, PhD
mederunoke@gmail.com
+36303987970
Backup
Agnes Jermendy, MD, PhD
jermendy@gmail.com
+36204600798
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2030-12
Participants
Target number of participants: 80
Treatments
No_intervention: Control
Standard care for moderate or severe hypoxic-ischemic encephalopathy with hypothermia.
Experimental: Intranasal breast milk
Fresh own mother's breast milk expressed within 4 hours, will be administered 2 times daily, 0.4 ml in each nostril for 28 days.
Related Therapeutic Areas
Sponsors
Leads: Semmelweis University