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Completed

NCT Number: NCT03914690

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

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.

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Key information

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

About this study

IVH is one of the most common complications in preterm infants. Nearly 60% of preterm infants with grade III-IV IVH develop severe neurodevelopmental outcomes. There are currently no effective treatments to prevent preterm infants with IVH from developing ventricular dilation or serious neurological disabilities. Recent studies have shown that EPO could improve neurodevelopmental outcomes in preterm infants with grade III-IV IVH. However, the dose and course of EPO in preterm infants is still uncertain. The purpose of the study was whether repeated low-dose EPO (500 U/kg, every other day, for 2 weeks) given to very preterm right after the diagnosis of IVH could improve long-term neurological outcomes. Very preterm infants with gestational age of ≤ 32 weeks who are diagnosed with IVH within 72 hours after birth in NICU are eligible for enrolment. After informed consent is obtained, infants will be randomly assigned to EPO group or vehicle group. The primary outcome is whether EPO improves mortality and neurological disabilities in very preterm infants with IVH at 18 months of corrected age, and the secondary outcome was whether EPO decrease the incidence of cerebral palsy, MDI<70, blindness, and deafness.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preterm infants admitted to NICU ≤ 32 weeks gestation at birth
  • Birth weight less than 1500 g
  • Less than 72 hours of life at time of enrolment
  • Diagnosed as IVH by head ultrasound
  • Written informed consent of parent or guardian

Exclusion criteria

  • Genetic metabolic diseases
  • Congenital abnormalities
  • Polycythaemia (Hct > 65%) within first 24 hours of life
  • Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life
  • Unstable vital signs (such as respiration and circulation failure)

Treatment and study plan

Erythropoietin

Drug

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

Other names: Epoietin Beta

normal saline

Drug

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.

Primary outcomes

  1. Mortality

    Time frame: At corrected age of 18 months

    To compare the death rate in EPO treatment and control groups at 18 months of corrected age.

  2. Incidence of neurological disability

    Time frame: At corrected age of 18 months

    To evaluate neurodevelopmental function via Bayley Infant Development scale (2nd Edition), visual acuity and auditory brainstem response measurements at 18 months of corrected age.

Secondary outcomes

  1. Incidence of cerebral palsy

    Time frame: At corrected age of 18 months

    To compare the incidence of cerebral palsy in EPO treatment and control groups at 18 months of corrected age.

  2. Incidence of MDI<70

    Time frame: At corrected age of 18 months

    To compare the incidence of MDI<70 via Bayley Infant Development scale (2nd Edition) in EPO treatment and control groups at 18 months of corrected age.

  3. Incidence of blindness

    Time frame: At corrected age of 18 months

    To compare the incidence of blindness via visual acuity and sight radius examinations in EPO treatment and control groups at 18 months of corrected age.

  4. Incidence of deafness

    Time frame: At corrected age of 18 months

    To compare the incidence of deafness via auditory brainstem response measurements in EPO treatment and control groups at 18 months of corrected age.

  5. The effect of EPO treatment on blood mRNA expression

    Time frame: At 3 weeks after birth

    To investigate different mRNA expression between EPO and control group, peripheral venous blood of preterm infants after EPO treatment will be collected in both EPO group and control group, and the transcriptome of the premature infant blood will be assayed by RNA sequencing.

Sponsors and collaborators

Lead sponsor

Zhengzhou University

Other

Collaborators

  • Göteborg University
  • Zhengzhou Children's Hospital, China

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Feb 26, 2021

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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