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 range

48 Hours

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

48 Hours

Sex

ALL

See this in plain English?

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