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PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns

NCT03079167 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2024-06-05

No results posted yet for this study

Summary

Double-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic encephalopathy in infants receiving hypothermia. The study aim is to determine whether Epo in conjunction with hypothermia in infants with moderate/severe hypoxic ischaemic encephalopathy (HIE) will improve neurodevelopmental outcomes at 2 years of age, without significant adverse effects, when compared to hypothermia alone.

Conditions

  • Hypoxic-Ischemic Encephalopathy

Interventions

DRUG

Epoetin Alfa

DRUG

Normal saline

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • University of Sydney

    lead OTHER

Principal Investigators

  • Helen Liley, BHB, MBChB · University of Sydney

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
23 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-14
Primary Completion
2023-11-30
Completion
2024-04-30

Countries

  • Australia
  • New Zealand
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03079167 on ClinicalTrials.gov