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New treatment option for Hypoxic-Ischaemic Encephalopathy
Official title Intranasal Breast Milk Therapy in HIE
ClinicalTrials.gov ID: NCT06746532
What this study is testing
What is Intranasal breast milk?
Intranasal breast milk is an investigational medicine, given as an once-daily, being studied as a potential treatment for hypoxic-ischaemic encephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 48
You may be able to join if
- Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia ≥ 35. gestational week \< 48 hours of life
- Hypothermia treatment for 72 hours
- Parental consent form
You likely can't join if
- Congenital malformation
- Concurrent cerebral lesions
- ECMO therapy
- Contraindication of lactation
- Mother unable or unwilling to provide fresh breast milk
- Postpartum asphyxia
The study team makes the final eligibility decision.
Where it's taking place
- Budapest, Hungary
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 48 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Budapest, Hungary. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.