Erythropoietin in Premature Infants to Prevent Encephalopathy: A Multi-Centre Randomized Blinded Controlled Study of the Efficacy of Erythropoietin in China
Who is this study for? Premature infants
What treatments are being studied? Epo
Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 2 days
Healthy Volunteers: f
View:
• Birthweight less or equal 1500 grams
• Less than 32 weeks gestation at birth
• Less than 48 hours of life at time of enrollment
• Written informed consent of parent or guardian
Locations
Other Locations
China
Children Hospital of Fudan University
Shanghai
Time Frame
Start Date: 2015-09-08
Completion Date: 2016-12-30
Participants
Target number of participants: 58
Treatments
Experimental: Erythropoietin
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 3 doses per week until at corrected age of 34 weeks.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: The Maternal & Children Health Hospital of Dehong, Yunnan of China, Maternal and Child Health Hospital of Hubei Province, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Guangzhou Women and Children's Medical Center, Second Affiliated Hospital of Wenzhou Medical University, Xiamen Children's Hospital, Fujian of China
Leads: Children's Hospital of Fudan University