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Effect of Erythropoietin on Preterm Brain Injury (EPO)

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ClinicalTrials.gov Identifier: NCT02036073
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Collaborator:
Zhengzhou University
Information provided by (Responsible Party):
Huiqing Sun, Zhengzhou Children's Hospital, China

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Premature Birth Drug: recombinant human erythropoietin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 490 participants
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : January 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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 Name: EPO




Primary Outcome Measures :
  1. Incidence of MDI<70 [ Time Frame: At corrected age of 18 months ]

Secondary Outcome Measures :
  1. Incidence of ROP [ Time Frame: At the corrected age 42 weeks ]


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Ages Eligible for Study:   up to 72 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036073


Locations
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China, Henan
Zhengzhou Children's Hospital
Zhengzhou, Henan, China, 450053
Sponsors and Collaborators
Zhengzhou Children's Hospital, China
Zhengzhou University

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Responsible Party: Huiqing Sun, Associate Professor, Zhengzhou Children's Hospital, China
ClinicalTrials.gov Identifier: NCT02036073     History of Changes
Other Study ID Numbers: CZZ-EPO
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Huiqing Sun, Zhengzhou Children's Hospital, China:
erythropoietin
preterm
brain injury
cerebral palsy
PVL
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Epoetin Alfa
Hematinics