Actively Recruiting

Early Phase 1
Age: 0 - 48Hours
All Genders
NCT06747260

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Led by Semmelweis University · Updated on 2025-05-22

10

Participants Needed

1

Research Sites

266 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Who Can Participate

Age: 0 - 48Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia
  • ≥ 35. gestational week
  • < 48 hours of life
  • Hypothermia treatment for 72 hours
  • Parental consent form
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Budapest, Hungary, 1083

Actively Recruiting

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Research Team

U

Unoke Meder, MD, PhD

CONTACT

A

Agnes Jermendy, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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