Skip to main content
OpenTrials
Completed

NCT Number: NCT03919500

Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Infant Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

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

NEC is one of the most severe complications in preterm neonates and is associated with high morbility and mortality. Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models. Evidence from previous clinical studies about the effect of EPO treatment against NEC have all been hampered by small numbers of patients. The study is to investigate whether repeated low-dose EPO protects against NEC. Preterm infants with gestational age ≤32 weeks who are admitted to neonatal intensive care units within 72 hours after birth are randomized to EPO (500IU/kg, intravenously every other day for 2 weeks) or control group (the same volume of saline). Primary outcome is the incidence of NEC at 36 weeks of corrected age. Secondary outcome is growth and neurodevelopment at 18 months of corrected age in infants with NEC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preterm infants with gestation age ≤ 32weeks
  • Within 72 hours after birth
  • Written informed consent obtained from parents

Exclusion criteria

  • Genetic or metabolic diseases
  • Congenital abnormalities
  • Polycythemia
  • Intracranial hemorrhage grade III/IV
  • Unstable vital signs (such as respiration and circulation failure)

Treatment and study plan

EPO

Drug

Infants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks.

Other names: Epoetin Beta

normal saline

Drug

Infants in control group are administered normal saline with the same volume and period as EPO.

Primary outcomes

  1. Incidence of NEC

    Time frame: At 36 weeks of corrected age

    To compare the incidence of NEC between EPO group and control group at 36 weeks of corrected age

Secondary outcomes

  1. Incidence of low height in patients with NEC

    Time frame: At corrected age of 18 months

    To compare the incidence of low height in patients with NEC between EPO and control groups via the Standardized Growth Curve for Chinese Children at 18 months of corrected age.

  2. Incidence of low weight in patients with NEC

    Time frame: At corrected age of 18 months

    To compare the incidence of low weight in patients with NEC between EPO and control group via the Standardized Growth Curve for Chinese Children at 18 months of corrected age.

  3. Incidence of low head circumference in patients with NEC

    Time frame: At corrected age of 18 months

    To compare the incidence of low head circumference in patients with NEC between EPO and control group via the Standardized Growth Curve for Chinese Children at 18 months of corrected age.

  4. Incidence of MDI<70 in patients with NEC

    Time frame: At corrected age of 18 months

    To compare the incidence of MDI<70 in patients with NEC between EPO and control group via Bayley Scales of Infant Development (second edition) at 18 months of corrected age.

  5. Incidence of cerebral palsy in patients with NEC

    Time frame: At corrected age of 18 months

    To compare the incidence of cerebral palsy in patients with NEC between EPO and control group at 18 months of corrected age.

  6. Incidence of blindness in patients with NEC

    Time frame: At corrected age of 18 months

    To compare the incidence of blindness in patients with NEC between EPO and control group via visual acuity at 18 months of corrected age.

  7. Incidence of deafness in patients with NEC

    Time frame: At corrected age of 18 months

    To compare the incidence of deafness in patients with NEC between EPO and control group via auditory brainstem response measurement at 18 months of corrected age.

  8. The effect of EPO treatment on blood messenger RNA (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
  • The First Affiliated Hospital of Zhengzhou University
  • Women and Children Health Care Center of Luoyang, China
  • Zhengzhou Children's Hospital, China

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Apr 19, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.