Intranasal Breast Milk Therapy in HIE

ConditionsHypoxic-Ischaemic Encephalopathy Neonatal Encephalopathy Perinatal Asphyxia Neonatal Hypoxic Ischemic Encephalopathy

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

AgeUp to 48

SponsorSemmelweis University

About this trial

This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.

Eligibility criteria

Qualifiers

Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia

Hypothermia treatment for 72 hours

Parental consent form

Disqualifiers

Congenital malformation

Concurrent cerebral lesions

ECMO therapy

Contraindication of lactation

Trial design

Treatments tested in this trial

Intranasal breast milk

Treatment groups

80 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Semmelweis University

Lead sponsor

Source ClinicalTrials.gov