Phase 3
N=500
High-dose Erythropoietin for Asphyxia and Encephalopathy
Neonatal Encephalopathy · Birth Asphyxia
Bottom Line
View on ClinicalTrials.gov: NCT02811263 ↗Enrolled (actual)
500
Serious AEs
48.6%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants With Death or Neurodevelopmental Impairment — 126; 110 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Normal saline placebo (Drug); Erythropoietin (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Death or Neurodevelopmental Impairment |
126; 110 | — |
| SECONDARY Number of Participants With Cerebral Palsy (CP) and Number of Participants With Each Type of Cerebral Palsy (CP), Determined Using a Standardized Neurologic Examination |
176; 173; 9; 6; 3; 2 | — |
| SECONDARY Number of Participants With Each Level of Gross Motor Function, Determined Using the GMFCS |
186; 178; 6; 6; 4; 6 | — |
| SECONDARY Bayley III Cognitive Score |
89.1; 89.5 | — |
| SECONDARY Bayley III Language Score |
87.9; 86.7 | — |
| SECONDARY Number of Participants With Epilepsy |
5; 4 | — |
| SECONDARY Number of Participants With Behavioral Abnormalities Determined by the Externalizing Score of the Child Behavior Checklist |
15; 3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- ≥ 36 weeks of gestational age
- Receiving active or passive whole body cooling/hypothermia since 65.0%)
- Parents/legal guardians with diminished capacity and autonomy
- Infant is participating or intends to participate in another interventional study during the birth hospitalization (note: does not include observational studies)
- Sentinel event and encephalopathy occurred only after birth
- Unable to consent in primary language of parent(s)
Data sourced from ClinicalTrials.gov (NCT02811263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.