Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Early Phase 1

Recruiting

• 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: Biological: Intranasal breast milk

• Registration Number: NCT06747260
• Lead Sponsor: Semmelweis University

Brief 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 we 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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-22
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-09-22
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia
• ≥ 35. gestational week
• < 48 hours of life
• Hypothermia treatment for 72 hours
• Parental consent form

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Exclusion Criteria

• Congenital malformation
• Concurrent cerebral lesions
• ECMO therapy
• Contraindication of lactation
• Mother unable or unwilling to provide fresh breast milk
• Postpartum asphyxia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intranasal breast milk	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.

Primary Outcome Measures

Name	Time	Method
Feasibility	1 months	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.

Secondary Outcome Measures

Name	Time	Method
Safety	1 month	As secondary outcome any adverse event associated with breast milk administration will be recorded, including desaturation (SpO2\<80%), bradycardia (heart rate \<70% of baseline) , apnea episode requiring bag and mask ventilation within 5 minutes of the intervention, or an increase in respiratory support (mode, setting, or FiO2 increase \>10%) within 1 hour of the intervention.
Time to reach full enteral feeding	1 month	Time to reach full enteral feeding will be recorded and analyzed as a secondary outcome.
Length of exclusive breast feeding	2 years	Lengths of exclusive breast feeding will be recorded and analyzed as a secondary outcome.

Trial Locations

Locations (1)

Division of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary; 🇭🇺 Budapest, Hungary