Intranasal Breast Milk Therapy in HIE

Early Phase 1

Recruiting

• Conditions: Hypoxic-Ischaemic Encephalopathy; Neonatal Encephalopathy; Perinatal Asphyxia; Neonatal Hypoxic Ischemic Encephalopathy
• Interventions: Biological: Intranasal breast milk

• Registration Number: NCT06746532
• Lead Sponsor: Semmelweis University

Brief 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.

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 open-label prospective randomized controlled single-center interventional study, the objective is to administer fresh, own-mother's breast milk intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days.

The primary objective is to compare neurodevelopmental outcomes between the control group and the intervention group receiving intranasal breast milk treatment. The secondary objective is to compare the progression of enteral feeding and the duration of exclusive breastfeeding between the intervention and the control group.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Study Start: 2025-02-01
• Primary Completion: 2028-01
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia

  ≥ 35. gestational week < 48 hours of life

• Hypothermia treatment for 72 hours

• Parental consent form

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
Neurodevelopmental outcome	2 years	The primary outcome will be the 2 year neurodevelopmental outcome comparing standard care and intranasal breast milk therapy groups.; The Bayley Scales of Infant Development, Third Edition (Bayley-III) score will be used to assess neurodevelopmental outcome, favorable outcome is defined as having composite scores for cognitive, language and motor scales \>85, while adverse outcome is defined as composite scores \<80 or death.

Secondary Outcome Measures

Name	Time	Method
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)

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