Using intranasal breast milk to improve outcomes in newborns with brain injury

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using breast milk to treat brain injury in newborns

  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.

  Recruiting Early Phase 1 Semmelweis University · Budapest · NCT06747260

• Newborn Brain Wave Checker: See if CergenX Wave matches the Sarnat exam

  This study tests whether the CergenX Wave software, which analyzes a newborn's EEG via a small four-electrode setup, can match the standard Sarnat examination in babies with suspected neonatal encephalopathy.

  Recruiting CergenX Limited · Dallas, Texas and 1 other locations · NCT07857070

• Continuous skin temperature monitoring in newborns during therapeutic hypothermia

  This study tests whether a wireless adhesive thermometer can safely and accurately monitor temperature in term and near-term newborns receiving therapeutic cooling.

  Recruiting Medical University of Graz · Graz, Styria · NCT07756892

• Neonatal Neurological Observation With Video AI

  This study tests a real-time, non-contact video AI system to help monitor brain health in newborns with suspected brain injury during their hospital stay.

  Recruiting Artemis AI Labs · New York, New York and 1 other locations · NCT07628829

• Genetic causes of neonatal encephalopathy and related conditions

  This project will see if DNA changes help explain neonatal encephalopathy in children under 6 who receive care at Boston Children's Hospital.

  Recruiting Boston Children's Hospital · Boston, Massachusetts · NCT07165938

• Monitoring brain and kidney blood flow in newborns with asphyxia during hypothermia treatment

  This study is testing how blood flow in the brains and kidneys of newborns with asphyxia changes during and after cooling treatment to see how it affects their health.

  Recruiting University of Erlangen-Nürnberg Medical School · Erlangen, Bavaria · NCT06611254

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.