Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

NCT03919500 | Completed Phase 2 DMC

• 1 other identifier: HN-2014002
• Study Type: interventional
• Target: 1,285
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Infant

Keywords

Preterm infant; Necrotizing enterocolitis; Erythropoietin; Neurodevelopment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of low height in patients with NEC

  At corrected age of 18 months

• Incidence of low weight in patients with NEC

  At corrected age of 18 months

• Incidence of low head circumference in patients with NEC

  At corrected age of 18 months

• Incidence of MDI<70 in patients with NEC

  At corrected age of 18 months

• Incidence of cerebral palsy in patients with NEC

  At corrected age of 18 months

Study Arms (2)

Erythropoietin

EXPERIMENTAL

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.

Drug: EPO

Normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

EPO DRUG

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

Also known as: Epoetin Beta

Erythropoietin

Normal saline DRUG

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

Normal saline

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with gestation age ≤ 32weeks
• Within 72 hours after birth
• Written informed consent obtained from parents

You may not qualify if:

• Genetic or metabolic diseases
• Congenital abnormalities
• Polycythemia
• Intracranial hemorrhage grade III/IV
• Unstable vital signs (such as respiration and circulation failure)

Sponsors & Collaborators

• Zhengzhou University: lead
• Zhengzhou Children's Hospital, China: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Women and Children Health Care Center of Luoyang, China: collaborator
• Göteborg University: collaborator

Study Sites (1)

Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Related Publications (2)

• Sun H, Song J, Kang W, Wang Y, Sun X, Zhou C, Xiong H, Xu F, Li M, Zhang X, Yu Z, Peng X, Li B, Xu Y, Xing S, Wang X, Zhu C. Effect of early prophylactic low-dose recombinant human erythropoietin on retinopathy of prematurity in very preterm infants. J Transl Med. 2020 Oct 19;18(1):397. doi: 10.1186/s12967-020-02562-y.

  PMID: 33076939 DERIVED

• Wang Y, Song J, Sun H, Xu F, Li K, Nie C, Zhang X, Peng X, Xia L, Shen Z, Yuan X, Zhang S, Ding X, Zhang Y, Kang W, Qian L, Zhou W, Wang X, Cheng X, Zhu C. Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial. J Transl Med. 2020 Aug 8;18(1):308. doi: 10.1186/s12967-020-02459-w.

  PMID: 32771013 DERIVED

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Interventions

epoetin beta; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Changlian Zhu, PhD

  Third Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical research center of Third Affiliated Hospitial

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 18, 2019
• Study Start: January 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be assessed by sponsor. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)