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NCT Number: NCT06746532

Intranasal Breast Milk Therapy in HIE

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.

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Key information

Conditions

Hypoxic-Ischaemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Neonatal Encephalopathy Neonatal Hypoxic Ischemic Encephalopathy Nervous System Diseases Pathological Conditions, Signs and Symptoms Perinatal Asphyxia Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary

Budapest, 1083, Hungary

Location status: Recruiting

Location contact

Miklos Szabo, MD, PhD

CONTACT

[email protected]

+36208258221

Unoke Meder, MD, PhD

CONTACT

[email protected]

+36303987970

Unoke Meder, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal breast milk

Biological

Own-mother's fresh breast milk (within 4 hours of having been expressed), is administered intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days.

Dose: 2 times daily, 0.4 ml in each nostril.

Primary outcomes

  1. Neurodevelopmental outcome

    Time frame: 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 outcomes

  1. Time to reach full enteral feeding

    Time frame: 1 month

    Time to reach full enteral feeding will be recorded and analyzed as a secondary outcome.

  2. Length of exclusive breast feeding

    Time frame: 2 years

    Lengths of exclusive breast feeding will be recorded and analyzed as a secondary outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Agnes Jermendy, MD, PhD

CONTACT

[email protected]

+36204600798

Unoke Meder, MD, PhD

CONTACT

[email protected]

+36303987970

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)

Acronym: NEO-BRIGHT

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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