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Recombinant Human Erythropoietin Improve Neurodevelopmental Outcomes in Extremely Preterm Infants

NCT02745990 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2021-08-31

No results posted yet for this study

Summary

In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and function were associated with intermittent or sustained systemic inflammation (ISSI). Since EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic properties. Based on its potential for neuroprotection, the prospective randomized and masked study was designed to determine whether rhEPO （500u/kg) was also effective in improving developmental outcomes for extremely low gestational age newborns.

Conditions

  • Developmental Disabilities

Interventions

DRUG

Recombinant human erythropoietin

rhEPO is administered 500IU/kg, intravenously within 72h after birth, and every other day up to 32 weeks of corrected age.

DRUG

Normal saline

Normal salin is administered the same volume with rhEPO intravenously within 72h after birth, and every other day up to 32 weeks of corrected age..

Sponsors & Collaborators

  • Zhengzhou University

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Huiqing Sun

    lead OTHER

Principal Investigators

  • Ligong Hou, BD · Zhengzhou Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2022-12-31
Completion
2022-12-31

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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 NCT02745990 on ClinicalTrials.gov