RecruitingEarly Phase 1NCT06747260

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy

Sponsor

Semmelweis University

Enrollment

10 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Max Age: 48 Hours

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Intranasal breast milk for people with brain injury, hypoxic ischaemic encephalopathy (hie), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include up to age 48 Hours.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALIntranasal 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).