Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

Premature Infant Clinical Trial

Official title:

Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919500
• Other study ID #: HN-2014002
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1285
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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)

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Premature Infant

Intervention

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

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (5)

Lead Sponsor	Collaborator
Zhengzhou University	Göteborg University, The First Affiliated Hospital of Zhengzhou University, Women and Children Health Care Center of Luoyang, China, Zhengzhou Children's Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of NEC	To compare the incidence of NEC between EPO group and control group at 36 weeks of corrected age	At 36 weeks of corrected age
Secondary	Incidence of low height in patients with NEC	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.	At corrected age of 18 months
Secondary	Incidence of low weight in patients with NEC	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.	At corrected age of 18 months
Secondary	Incidence of low head circumference in patients with NEC	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.	At corrected age of 18 months
Secondary	Incidence of MDI<70 in patients with NEC	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.	At corrected age of 18 months
Secondary	Incidence of cerebral palsy in patients with NEC	To compare the incidence of cerebral palsy in patients with NEC between EPO and control group at 18 months of corrected age.	At corrected age of 18 months
Secondary	Incidence of blindness in patients with NEC	To compare the incidence of blindness in patients with NEC between EPO and control group via visual acuity at 18 months of corrected age.	At corrected age of 18 months
Secondary	Incidence of deafness in patients with NEC	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.	At corrected age of 18 months
Secondary	The effect of EPO treatment on blood messenger RNA (mRNA) expression	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.	At 3 weeks after birth