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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 gestational age
* ≤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