Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

Zhengzhou University

Status and phase: Completed; Phase 2

Conditions: Premature Infant

Treatments: Drug: EPO; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03919500

HN-2014002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,285 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,285 participants in 2 patient groups, including a placebo group

Erythropoietin

Experimental group

Description:

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.

Treatment:

Drug: EPO

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline