RecruitingEarly Phase 1

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Hungary10 participantsStarted 2024-11-22

Plain-language 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.

Who can participate

Age range48 Hours

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia * ≥ 35. gestational week * \< 48 hours of life * Hypothermia treatment for 72 hours * Parental consent form Exclusion Criteria: * Congenital malformation * Concurrent cerebral lesions * ECMO therapy * Contraindication of lactation * Mother unable or unwilling to provide fresh breast milk * Postpartum asphyxia

What they're measuring

Proportion of patients where treatment was initiated within 48 hours

Timeframe: 1 months

Trial details

NCT IDNCT06747260

SponsorSemmelweis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-22

Contact for this trial

Unoke Meder, MD, PhD

+36303987970 mederunoke@gmail.com

View on ClinicalTrials.gov More Hypoxic Ischaemic Encephalopathy (HIE) trials