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Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Study acronym: F-NEO-BRIGHT
StatusRecruiting
PhaseEarly Phase 1
Started
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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.

Record History

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  1. Primary endpoint revised
    • Secondary endpoints: 3 to 4
    • Study description revised
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06747260
Lead Sponsor Semmelweis University
Conditions
(from sponsor)		 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
Related terms Brain Injuries, Hypoxia-Ischemia, Brain
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov