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Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

Premature Infant Clinical Trial

Official title:
Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03919500
Study type Interventional
Source Zhengzhou University
Contact
Status Completed
Phase Phase 2
Start date January 2014
Completion date April 2019
View Details
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