Neonatal Intranasal Breast Milk Impact on Brain Growth in Hypoxic-Ischemic Encephalopathy Therapy (NEO-BRIGHT)

What this Trial Is About

Researchers are evaluating the effect of intranasal breast milk on long-term brain development in newborns with moderate to severe hypoxic-ischemic encephalopathy (HIE) who are receiving therapeutic hypothermia. HIE, caused by perinatal asphyxia, is a major cause of newborn death and lasting brain issues. This open-label, randomized controlled trial aims to improve neurodevelopmental outcomes by adding fresh breast milk treatment to standard care. The study compares two groups: one receiving standard care with therapeutic hypothermia and the other receiving the same care plus intranasal administration of fresh own-mother's breast milk. The breast milk is given twice daily, 0.4 ml in each nostril, starting from the first day of life and continuing for 28 days. This method is based on evidence that breast milk contains beneficial factors that may reduce brain injury. Participants will be closely followed to assess neurodevelopment at 2 years, the time taken to reach full enteral feeding by 1 month, and the duration of exclusive breastfeeding up to 2 years. The study includes regular monitoring to evaluate feeding progression, breastfeeding duration, and overall brain growth. The total participation period covers these assessments to track long-term effects and safety of the intranasal breast milk therapy.

Intranasal Breast Milk Therapy in HIE