Using intranasal breast milk to improve outcomes in newborns with brain injury
Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)
This study is testing if giving fresh breast milk through the nose can help newborns with brain injury do better in the long run compared to standard care.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | N/A to 48 Hours |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT06746532 on ClinicalTrials.gov |
What this trial studies
This open-label, prospective, single-center randomized controlled trial aims to evaluate the effects of intranasal administration of fresh breast milk on long-term neurodevelopmental outcomes in neonates diagnosed with hypoxic-ischemic encephalopathy (HIE) who are undergoing therapeutic hypothermia. The study will involve administering the breast milk starting from the first day of life and continuing for 28 days. The primary objective is to compare the neurodevelopmental outcomes of infants receiving intranasal breast milk with those receiving standard care. The research is based on the premise that bioactive components in breast milk may help reduce neurological damage in affected infants.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates with moderate to severe hypoxic-ischemic encephalopathy who are receiving therapeutic hypothermia and are less than 48 hours old.
Not a fit: Patients with congenital malformations, concurrent cerebral lesions, or those unable to provide fresh breast milk will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve neurodevelopmental outcomes for neonates suffering from HIE.
How similar studies have performed: While the use of intranasal breast milk is a novel approach, animal studies have shown promising results regarding its safety and potential benefits in reducing neurological damage.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Budapest
- Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary — Budapest, Hungary (Recruiting)
Study contacts
- Principal investigator: Unoke Meder, MD, PhD — Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary
- Study coordinator: Unoke Meder, MD, PhD
- Email: mederunoke@gmail.com
- Phone: +36303987970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.