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Feasibility and Safety of Intranasally Administered Breast Milk in HIE

NCT06747260 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-22

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

BIOLOGICAL

Intranasal breast milk

Neonates with hypoxic-ischemic encephalopathy receive their own-mother's fresh breast milk intranasally, starting from the first 48 hours of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril (15 minutes apart).

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2025-09-22
Completion
2030-01-01

Countries

  • Hungary

Study Locations

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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 NCT06747260 on ClinicalTrials.gov