Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Not Recruiting

Trial ID: NCT03169881

Purpose

Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

Official Title

Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - Inborn and outborn preterm infants

   - 23 0/7-28 6/7 weeks gestation

   - ≤24 hours postnatal age

Exclusion Criteria:

   - Hematocrit > 60%

   - Infants with known congenital or chromosomal anomalies, including congenital heart
   disease and known brain anomalies

   - Hemorrhagic or hemolytic disease

   - EEG- confirmed seizures

   - Congenital thrombotic disease

   - Systolic blood pressures >100 mm Hg while not on pressor support

   - Receiving Epo or Darbe clinically, or planning to receive Epo or Darbe during
   hospitalization

   - Infants in whom no aggressive therapy is planned

   - Family will NOT be available for follow-up at 22-26 months

Intervention(s):

drug: Darbepoetin

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa Van Meurs
6507235711