Feasibility and Safety of Intranasally Administered Breast Milk in HIE (F-NEO-BRIGHT)

Semmelweis University

Status and phase: Enrolling; Early Phase 1

Conditions: Perinatal Asphyxia; Perinatal Asphyxia , Moderate to Severe HIE; Brain Injury; Hypoxic Ischemic Encephalopathy of Newborn; Neonatal Encephalopathy; Neonatal Hypoxic Ischemic Encephalopathy; Hypoxic Ischaemic Encephalopathy (HIE)

Treatments: Biological: Intranasal breast milk

Study type: Interventional

Funder types: Other

Identifiers

NCT06747260

SE-NEONAT-03/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intranasal breast milk

Experimental group

Description:

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.

Treatment:

Biological: Intranasal breast milk