Erythropoietin in Premature Infants to Prevent Encephalopathy

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborators: Guangzhou Women and Children's Medical Center; Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region; Maternal and Child Health Hospital of Hubei Province; Second Affiliated Hospital of Wenzhou Medical University; The Maternal & Children Health Hospital of Dehong, Yunnan of China; Xiamen Children's Hospital, Fujian of China
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

1. Birthweight less or equal 1500 grams

2. Less than 32 weeks gestation at birth

3. Less than 48 hours of life at time of enrollment

4. Written informed consent of parent or guardian

Exclusion Criteria:

1. Intrauterine Growth Retardation

2. Severe Congenital Anomalies adversely affecting life expectancy or neurodevelopment

3. Genetic Metabolic Diseases

4. Seizures within first 24 hours of life

5. Severe neutropenia (ANC < 500 cells/microL) within first 24 hours of life

6. Polycythemia (Hct > 65%) within first 24 hours of life

7. Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life

8. Hypertension (SBP > 100mmHg) without vasopressor support within first 24 hours of life

9. Microcephaly

10. Grade III-IV intracranial hemorrhage

Termination

1. Required by parent or guardian;

2. Polycythemia through blood transfusion can not be relieved

3. Oliguria（<0.5mL/kg/h for at least 24 hours）

4. Progression of azotemia

5. Pulmonary hypertension or Cardiac arrhythmia