High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL)

NCT02811263 Phase 3 COMPLETED Results posted

Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen to the brain near the time of birth. This results in death or neurologic disabilities including cerebral palsy and cognitive impairment in up to half of affected infants. This clinical trial will determine if the drug erythropoietin (Epo) added to hypothermia (usual therapy) will improve outcomes for infants suffering from HIE.

Details

Lead sponsor	University of California, San Francisco
Phase	Phase 3
Status	COMPLETED
Enrolment	500
Start date	2017-01
Completion	2022-04

Conditions

• Neonatal Encephalopathy
• Birth Asphyxia

Interventions

• Normal saline placebo
• Erythropoietin

Primary outcomes

• Number of Participants With Death or Neurodevelopmental Impairment — Prior to final outcome assessment at 22-26 months of age; For extenuating circumstances, for example, COVID-19 restrictions, may be performed up to 36 months of age
  Neurodevelopmental impairment defined as any of the following: a) Gross Motor Function Scale (GMFCS) level ≥ 1, or b) GMFCS = 0 or 0.5 and cerebral palsy (CP) (any type), or c) Bayley III Cognitive Score \< 90

Countries

United States