NCT06746532 Intranasal Breast Milk Therapy in HIE
| NCT ID | NCT06746532 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Semmelweis University |
| Condition | Hypoxic-Ischaemic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-02-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Moderate or severe hypoxic- ischemic 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
Contact & Investigator
Unoke Meder, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary
Frequently Asked Questions
Who can join the NCT06746532 clinical trial?
This trial is open to participants of all sexes, up to 48 Hours, studying Hypoxic-Ischaemic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06746532 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06746532 currently recruiting?
Yes, NCT06746532 is actively recruiting participants. Contact the research team at mederunoke@gmail.com for enrollment information.
Where is the NCT06746532 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT06746532 clinical trial?
NCT06746532 is sponsored by Semmelweis University. The principal investigator is Unoke Meder, MD, PhD at Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary. The trial plans to enroll 80 participants.