Effect of Erythropoietin on Preterm Brain Injury (EPO)

January 13, 2014 updated by: Huiqing Sun, Zhengzhou Children's Hospital, China
EPO has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological indicators and explore the neuroprotective mechanism of EPO.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants, which is related with the development of cerebral palsy. The current therapy is only supportive to maintain the live sign stable. There is no effective therapeutic strategy for preterm brain injury. Erythropoietin (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries in animal models of brain injury, and clinical trials of neonatal hypoxic ischemic brain injury. Furthermore, recombinant human Epo (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity during the past decade. It has been considered to be safe and well tolerated in preterm infants. However, there is no conclusion yet if the EPO has the effect to prevent preterm brain injury. The purpose of the study was whether the rhEpo (500 U/kg) given to very preterm infants (gestation age < 32 weeks) within 24h after birth and subsequently each other day for2 week possesses neuroprotective properties. Very preterm infants with gestational age of < 32 weeks and admit to our NICU are eligible for enrollment. After informed consent is obtained, infants will be randomly assigned to either EPO group or vehicle group. The primary short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL)) and ROP. The long term outcomes are whether rhEpo in very preterm infants finally improves neurodevelopmental outcome at 18 months corrected age.

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450053
        • Zhengzhou Children'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm infants admitted to the NICU with gestational age <32 weeks
  • birth weight <1500g and less than 72hours of age

Exclusion Criteria:

  • 1. Infants with genetic metabolic diseases

    2. Congenital abnormalities

    3. Pneumothorax

    4. Grade III-IV intracranial hemorrhage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPO
In EPO group, the EPO was given by 500IU/kg every other day intravenously for 2 weeks. Recombinant human erythropoietin was configured by the hospital pharmacy intravenous Center Configuration, melted configured with saline to 1ml/kg solution. For severe patients, they were started to treat with EPO when their vital signs, blood pressure were stable.
Drug: recombinant human erythropoietin
rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.
Other Names:
  • EPO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of MDI<70
Time Frame: At corrected age of 18 months
At corrected age of 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of ROP
Time Frame: At the corrected age 42 weeks
At the corrected age 42 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhengzhou Children's Hospital, China

Collaborators

Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZZ-EPO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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