Overview

Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage

Status:
Completed
Trial end date:
2019-07-01
Target enrollment:
0
Participant gender:
All
Summary
Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). The aim of this study is to evaluate the long-term neuroprotective effect of repeated low-dose EPO (500 U/kg) in very preterm infants with IVH.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhengzhou University
Collaborators:
Göteborg University
Zhengzhou Children's Hospital, China
Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:

- Preterm infants admitted to NICU ≤ 32 weeks gestation at birth

- Birth weight less than 1500 g

- Less than 72 hours of life at time of enrolment

- Diagnosed as IVH by head ultrasound

- Written informed consent of parent or guardian

Exclusion Criteria:

- Genetic metabolic diseases

- Congenital abnormalities

- Polycythaemia (Hct > 65%) within first 24 hours of life

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

- Unstable vital signs (such as respiration and circulation failure)