Intranasal Breast Milk Therapy in HIE

Launched by SEMMELWEIS UNIVERSITY · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of giving breast milk through the nose (intranasal) to newborns who have a serious condition called hypoxic-ischemic encephalopathy (HIE). This condition occurs when a baby does not get enough oxygen to the brain, often due to complications during birth. The trial aims to see if this breast milk therapy, combined with a cooling treatment known as therapeutic hypothermia, can improve the long-term brain development of these babies compared to standard care.

To participate in the trial, babies must be between 0 and 2 days old, have moderate to severe HIE, and be receiving the cooling treatment. Parents will need to provide consent for their baby to join the study. Unfortunately, babies with certain conditions, like major birth defects or those whose mothers cannot provide fresh breast milk, will not be eligible. If families choose to take part, they can expect close monitoring and support throughout the trial to ensure the best care for their baby.

Gender

ALL

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