Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Launched by SEMMELWEIS UNIVERSITY · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and feasibility of giving breast milk through the nose of newborns who have a serious brain condition called hypoxic-ischaemic encephalopathy (HIE). HIE happens when a baby doesn't get enough oxygen at birth, which can lead to brain injury. The trial is focused on babies who are receiving a special treatment called therapeutic hypothermia, which helps protect their brain while they recover. The goal is to see if this method of feeding can be done safely and effectively.

To participate in the trial, babies must be at least 35 weeks old, be diagnosed with moderate to severe HIE, and be less than 48 hours old. Parents will need to give their consent for their baby to be part of the study. During the trial, babies will receive breast milk through their nose while they undergo cooling treatment for 72 hours. It’s important to note that babies with certain conditions, like congenital malformations or those who are on certain life-support treatments, will not be eligible for this study. Overall, this trial aims to explore a new way to provide nutrition to newborns with HIE while ensuring their safety during treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Moderate or severe hypoxic- ischaemic 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