Effect of Erythropoietin in Premature Infants on White Matter Lesions and Neurodevelopmental Outcome

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Preterm and very preterm infants are at risk of developing encephalopathy of prematurity and long-term neurodevelopmental delay. Magnetic resonance imaging (MRI) allows the characterization of specific features of encephalopathy of prematurity, including structural changes of brain white matter and gray matter. This study wants to investigate important evidence that early repeated high-dose rhEPO(5250 IU/kg) treatment improves long-term neurological outcomes in very preterm infants and without obvious adverse effects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Northwest Women and Children's Hospital; Second Affiliated Hospital of Xi'an Jiaotong University; Second Affiliated Hospital of Xi'an Medical University; Shaanxi Provincial People's Hospital; Tang-Du Hospital; Xi'an Children's Hospital; Xi'an No.4 Hospital; Xian Children's Hospital; Xijing Hospital
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• premature infants who admitted to the neonatal intensive care unit(NICU) Within 72 hours after birth, gestational ages younger than 32 weeks, birth weight less than 1500 gram, informed consent was obtained from the infants' parents or guardians

Exclusion Criteria:

• born with anemia, polycythemia, hemolysis and other hematological diseases

• hypertension,

• convulsions,

• a genetically defined syndrome

• a severe congenital malformation adversely affecting life expectancy or neurodevelopment

• severe intraventricular hemorrhage

• thrombosis disease

• other fatal diseases or which can seriously affect the prognosis