Safety and Feasibility of Using Intranasal Breast Milk in Newborns with Moderate to Severe Hypoxic-Ischemic Encephalopathy Undergoing Cooling Treatment

What this Trial Is About

Hypoxic-ischemic encephalopathy HIE in newborns is a serious condition caused by lack of oxygen and blood flow to the brain around the time of birth, leading to high risk of death and long-term brain problems. Therapeutic hypothermia is currently the only treatment proven to reduce brain damage in these infants. Researchers are exploring if giving breast milk through the nose can be a safe and feasible additional treatment to support brain health in babies with HIE. In this study, newborns with moderate to severe HIE who are receiving therapeutic hypothermia will be given their own mothers fresh breast milk intranasally. The breast milk, expressed within 4 hours, will be administered twice daily with 0.4 ml in each nostril, starting within 48 hours after birth and continuing for 28 days. The study focuses on whether this treatment can be started quickly and safely in these infants. Participants will be monitored closely for vital signs and any side effects during the treatment period. Researchers will track how soon full feeding by mouth is reached, the duration of exclusive breastfeeding, and any adverse events related to the breast milk administration. The main measure is the proportion of babies who receive the treatment within 48 hours of birth, with follow-up extending over the first month and breastfeeding tracked for up to two years.

Feasibility and Safety of Intranasally Administered Breast Milk in HIE