Intranasal Breast Milk Therapy in HIE (NEO-BRIGHT)

Semmelweis University

Status and phase: Enrolling; Early Phase 1

Conditions: Perinatal Asphyxia; Neonatal Encephalopathy; Neonatal Hypoxic Ischemic Encephalopathy; Hypoxic-Ischaemic Encephalopathy

Treatments: Biological: Intranasal breast milk

Study type: Interventional

Funder types: Other

Identifiers

NCT06746532

NNGYK/40202-5/2024

Details and patient eligibility

About

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.

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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Control

No Intervention group

Description:

Standard care for moderate or severe hypoxic-ischemic encephalopathy with hypothermia.

Intranasal breast milk

Experimental group

Description:

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.

Treatment:

Biological: Intranasal breast milk