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Intranasal Breast Milk Therapy in HIE

NCT06746532 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-12-24

No results posted yet for this study

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.

Conditions

  • Hypoxic-Ischaemic Encephalopathy
  • Neonatal Encephalopathy
  • Perinatal Asphyxia
  • Neonatal Hypoxic Ischemic Encephalopathy

Interventions

BIOLOGICAL

Intranasal breast milk

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.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Unoke Meder, MD, PhD · Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2028-01-31
Completion
2030-12-31

Countries

  • Hungary

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746532 on ClinicalTrials.gov