NCT06747260

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 48 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. Based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in HIE neonates. Improving neurodevelopmental outcomes of newborns with HIE has been an intense area of research over the past decade. Breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. Studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. Animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. In preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated. In this prospective study our aim is to assess the feasibility and safety of intranasally delivered breast milk to HIE infants treated with hypothermia. Our objective is to administer fresh, own-mother's breast milk intranasally to neonates with HIE starting from the first day of life and continuing for 1 month. Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk expressed within 4 hours and continuing treatment after discharge until day 28. Safety will be assessed through monitoring vital signs and documenting any adverse events. Time to reach full enteral feeding and lengths of exclusive breast feeding will be recorded and analyzed.

Conditions

• 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

Interventions

Type	Name	Description
BIOLOGICAL	Intranasal breast milk	Neonates with hypoxic-ischemic encephalopathy receive their own-mother's fresh breast milk intranasally, starting from the first 48 hours of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril (15 minutes apart).

Timeline

• Start date: 2024-11-22
• Primary completion: 2025-09-22
• Completion: 2030-01-01
• First posted: 2024-12-24
• Last updated: 2025-05-22

Locations

1 site across 1 country: Hungary