Erythropoietin in Premature Infants to Prevent Encephalopathy

Summary

The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months corrected age. This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 312 patients.

Conditions

• Premature Infant

Interventions

DRUG

Epo

Epo is administered 1000 U/kg, iv in 48 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, subcutaneously 400 U/Kg per injection and 3 doses per week until at corrected age of 34 weeks.

DRUG

Normal saline

Normal saline is administered 5ml, iv at 3 to 6 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, Subcutaneously 3 doses per week until at corrected age of 34 weeks.

Sponsors & Collaborators

• Xiamen Children's Hospital, Fujian of China

  collaborator OTHER

• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Maternal and Child Health Hospital of Hubei Province

  collaborator OTHER

• The Maternal & Children Health Hospital of Dehong, Yunnan of China

  collaborator OTHER

• Children's Hospital of Fudan University

  lead OTHER

Principal Investigators

• Wenhao Zhou, Doctor · Children's Hospital of Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-08

Primary Completion

2016-12-30

Completion

2016-12-30

Countries

• China

Study Locations