Using breast milk to treat brain injury in newborns
Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy
This study is testing if giving breast milk through the nose can help newborns with brain injuries feel better and develop normally while they are being treated with cooling therapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | N/A to 48 Hours |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT06747260 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of administering breast milk intranasally to neonates suffering from hypoxic-ischaemic encephalopathy (HIE) who are undergoing therapeutic hypothermia. The research aims to determine if this method can improve neurodevelopmental outcomes by leveraging the bioactive components found in breast milk, such as stem cells and neurotrophic factors. The intervention involves delivering fresh breast milk from the infant's mother starting within 48 hours of birth and continuing for one month. The study is conducted at a single center and focuses on the initial safety and practicality of this approach.
Who should consider this trial
Good fit: Ideal candidates are neonates diagnosed with moderate to severe hypoxic-ischaemic 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 enhance neurodevelopmental outcomes in newborns affected by HIE.
How similar studies have performed: While the use of breast milk in this manner is novel, previous studies have indicated that intranasal administration of breast milk is safe in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Budapest
- Division 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.