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

NCT06746532 EARLY_PHASE1 RECRUITING

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.

Details

Lead sponsor	Semmelweis University
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	80
Start date	2025-02-01
Completion	2030-12

Conditions

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

Interventions

• Intranasal breast milk

Primary outcomes

• Neurodevelopmental outcome — 2 years
  The primary outcome will be the 2 year neurodevelopmental outcome comparing standard care and intranasal breast milk therapy groups. The Bayley Scales of Infant Development, Third Edition (Bayley-III) score will be used to assess neurodevelopmental outcome, favorable outcome is defined as having composite scores for cognitive, language and motor scales \>85, while adverse outcome is defined as composite scores \<80 or death.

Countries

Hungary