NCT03919500

Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,285 (actual)
• Sponsor: Zhengzhou University · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Premature Infant

Interventions

Type	Name	Description
DRUG	EPO	Infants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks.
DRUG	Normal saline	Infants in control group are administered normal saline with the same volume and period as EPO.

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2019-04-18
• Last updated: 2019-04-19

Locations

1 site across 1 country: China