CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 500 enrolled
Drug / intervention
Normal saline placebo +1 moredrug
Likely dose
Erythropoietin (Epogen) 4000U/mL from commercially available single-dose vials; specific mg/kg dosing not stated in provided textAI-extracted
Key inclusion· 4
  • ✓Gestational age ≥36 weeks
  • ✓Receiving active or passive whole body cooling/hypothermia started before 6 hours of age
  • ✓Perinatal depression: Apgar <5 at 10 min, need for resuscitation at 10 min, pH <7.00 in cord or early infant gas, or base deficit ≥15 mmol/L
  • ✓Moderate to severe encephalopathy by modified Sarnat exam between 1–6 hours after birth
Key exclusion· 10
  • ✕Study drug cannot be administered within 26 hours of birth
  • ✕Infant has living twin or higher-order multiple also being cooled
  • ✕Birth weight <1800 g
  • ✕Genetic or congenital condition affecting neurodevelopment or requiring multiple surgeries

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02811263
NCT02811263Phase 3Completed
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High-dose Erythropoietin for Asphyxia and Encephalopathy

University of California, San Francisco·interventional·Posted Jun 23, 2016·Updated Jan 30, 2023

In Brief

A Phase 3 clinical trial evaluating Normal saline placebo and Erythropoietin for Neonatal Encephalopathy and Birth Asphyxia. Completed, enrolled 500 participants across 23 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Encephalopathy, Birth Asphyxia
CountriesUnited States
CollaboratorsUniversity of Washington, Pediatrix, University of Utah, Children's National Research Institute, University of Minnesota, University of Texas, Washington University School of Medicine, Indiana University, Stanford University, University of Pittsburgh, Children's Hospital Los Angeles, Nationwide Children's Hospital, Boston University, University of New Mexico, University of Chicago, University of North Carolina, Vanderbilt University, Children's Hospital Medical Center, Cincinnati, Johns Hopkins University, Cook Children's Medical Center, Children's Hospital of Philadelphia

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 23, 2016
Enrollment StartJan 1, 2017
Primary CompletionOct 1, 2021
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.0 years ago

Interventions

Normal saline placebodrug

Equal volume of normal saline to be used as placebo

Erythropoietindrug

Epogen drawn from commercially available single dose 4000U/mL vials