Overview

Recombinant Human Erythropoietin Improve Neurodevelopmental Outcomes in Extremely Preterm Infants

Status:
Enrolling by invitation
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
Summary
In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and function were associated with intermittent or sustained systemic inflammation (ISSI). Since EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic properties. Based on its potential for neuroprotection, the prospective randomized and masked study was designed to determine whether rhEPO （500u/kg) was also effective in improving developmental outcomes for extremely low gestational age newborns.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Huiqing Sun
Collaborators:
Göteborg University
Zhengzhou University
Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:

- Preterm infants admitted to NICU wuth gestational age less than 28 weeks

- Age less than 3 days;

- parental informed consent.

Exclusion Criteria:

- Major life-threatening anomalies (brain, cardiac, chromosomal anomalies)

- Hematologic crises such as DIC, or hemolysis due to blood group incompatibilities

- Polycythemia (hematocrit > 65);

- Hypertension

- Seizures

- Congenital infection