Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 2 days
Healthy Volunteers: f
View:
• Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia
• ≥ 35. gestational week
• \< 48 hours of life
• Hypothermia treatment for 72 hours
• Parental consent form
Locations
Other Locations
Hungary
Division 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: 2024-11-22
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 10
Treatments
Experimental: Intranasal breast milk
Study participants receive their own mother's fresh breast milk, expressed within 4 hours, administered 2 times daily, 0.4 ml in each nostril for 28 days.
Related Therapeutic Areas
Sponsors
Leads: Semmelweis University