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

What this Trial Is About

This research investigates the use of intranasal breast milk in newborns with hypoxic-ischemic encephalopathy (HIE) who are undergoing therapeutic hypothermia. HIE results from perinatal asphyxia and is a leading cause of neonatal death and long-term brain disabilities. While therapeutic hypothermia is the only proven treatment to reduce brain damage in HIE, this study explores whether adding intranasal breast milk can improve long-term brain development and cognitive outcomes. The study is an open-label, randomized controlled trial conducted at a single center. Fresh breast milk from the baby's own mother, expressed within 4 hours, is given intranasally twice daily (0.4 ml in each nostril) starting from the first day of life and continuing for 28 days. This treatment is compared to standard care without intranasal breast milk. Both groups receive therapeutic hypothermia for 72 hours as part of standard treatment. Participants will be monitored for neurodevelopmental outcomes over two years. Researchers will also track progress in feeding and the duration of exclusive breastfeeding. The study includes assessments of brain growth and safety evaluations. The total involvement includes treatment and follow-up to understand the impact on brain development and feeding progress in these newborns.

Intranasal Breast Milk Therapy in HIE