Using breast milk to treat brain injury in newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.