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Completed

NCT Number: NCT02036073

Effect of Erythropoietin on Preterm Brain Injury

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Congenital abnormalities
  • Pneumothorax
  • Grade III-IV intracranial hemorrhage

Treatment and study plan

Recombinant human erythropoietin

Drug

rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.

Other names: EPO

Primary outcomes

  1. Incidence of MDI<70

    Time frame: At corrected age of 18 months

Secondary outcomes

  1. Incidence of ROP

    Time frame: At the corrected age 42 weeks

Sponsors and collaborators

Lead sponsor

Zhengzhou Children's Hospital, China

Other

Collaborators

  • Zhengzhou University

Registry information

Acronym: EPO

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jan 14, 2014
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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