Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Premature Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Erythropoietin

Infants in the EPO group are given EPO 500IU/kg dissolved in 2 ml saline intravenously every other day for 2 weeks starting within 72 hours after birth.

Group Type EXPERIMENTAL

EPO

Intervention Type DRUG

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

Normal saline

Infants in the control group are given normal saline intravenously with the same volume as EPO every other day for 2 weeks.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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EPO

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

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Epoetin Beta

Eligibility Criteria

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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)

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No