Phase 3
Completed N=500
High-dose Erythropoietin for Asphyxia and Encephalopathy
Neonatal encephalopathy · Birth Asphyxia
Source: ClinicalTrials.gov NCT02811263 ↗
Enrolled (actual)
500
Serious AEs
48.6%
Results posted
Jan 2023
Primary outcomePrimary: Number of Participants With Death or Neurodevelopmental Impairment — 126; 110 Participants
◆ Published Evidence
Highly cited
212citations · ~53 / year
Trial of Erythropoietin for Hypoxic-Ischemic Encephalopathy in Newborns.
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.
Linked Publications (5)
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Trial of Erythropoietin for Hypoxic-Ischemic Encephalopathy in Newborns.
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Acute and Chronic Placental Abnormalities in a Multicenter Cohort of Newborn Infants with Hypoxic-Ischemic Encephalopathy.
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Artificial Intelligence Outcome Prediction in Neonates with Encephalopathy (AI-OPiNE).
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Relationship of Neonatal Seizure Burden Before Treatment and Response to Initial Antiseizure Medication.
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Time to Reaching Target Cooling Temperature and 2-year Outcomes in Infants with Hypoxic-Ischemic Encephalopathy.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.