Clinical Trial

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Study acronym: F-NEO-BRIGHT
Recruiting Early Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated May 22, 2025 (before its estimated September 22, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-18.
Trial Details
NCT Number NCT06747260
Lead Sponsor Semmelweis University
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
Enrollment 10 participants
Start Date 2024-11-22
Primary Completion 2025-09-22 (estimated)
Study Completion 2030-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-22