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Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage

NCT03914690 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2021-02-26

No results posted yet for this study

Summary

Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). The aim of this study is to evaluate the long-term neuroprotective effect of repeated low-dose EPO (500 U/kg) in very preterm infants with IVH.

Conditions

  • Premature Infants

Interventions

DRUG

Erythropoietin

EPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.

DRUG

Normal saline

Normal saline is administered the same volume with EPO, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.

Sponsors & Collaborators

  • Zhengzhou Children's Hospital, China

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Zhengzhou University

    lead OTHER

Principal Investigators

  • Changlian Zhu, PhD · Third Affiliated Hospital of Zhengzhou University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • China

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 NCT03914690 on ClinicalTrials.gov