Feasibility and Safety of Intranasally Administered Breast Milk in HIE

ConditionsHypoxic Ischaemic Encephalopathy (HIE)Hypoxic Ischemic Encephalopathy of Newborn Neonatal Encephalopathy Neonatal Hypoxic Ischemic Encephalopathy Brain Injury Perinatal Asphyxia Perinatal Asphyxia , Moderate to Severe HIE

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

AgeUp to 48

SponsorSemmelweis University

About this trial

This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.

Eligibility criteria

Qualifiers

Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia

≥ 35. gestational week

< 48 hours of life

Hypothermia treatment for 72 hours

Disqualifiers

Congenital malformation

Concurrent cerebral lesions

ECMO therapy

Contraindication of lactation

Trial design

Treatments tested in this trial

Intranasal breast milk

Treatment groups

10 Participants

are divided into 1 treatment group

Locations

Division of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary1083, Budapest Hungary

Sponsors and collaborators

Semmelweis University

Lead sponsor

Source ClinicalTrials.gov