CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Erythropoietin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01913340
NCT01913340Phase 2Completed
CompareCT.gov

Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study

University of California, San Francisco·interventional·Posted Aug 1, 2013·Updated Jul 13, 2020

In Brief

A Phase 2 clinical trial evaluating Erythropoietin and Normal saline for Hypoxic-ischemic Encephalopathy and 2 related conditions. Completed, enrolled 50 participants across 7 sites.

Detailed Summary

Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical trial will determine if the drug erythropoietin, given with hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic deficits after HIE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
CountriesUnited States
CollaboratorsThrasher Research Fund, Seattle Children's Hospital, Arkansas Children's Hospital Research Institute, Washington University School of Medicine, Children's National Research Institute, Stanford University, Kaiser Permanente

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 1, 2013
Enrollment StartSep 1, 2013
Primary CompletionJan 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.9 years ago

Interventions

Erythropoietindrug

1000 U/kg/dose IV x 5 doses

Normal salinedrug

placebo: NS IV x 5 doses