Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Darbepoetin
  • Drug: Placebo

Phase:

Phase 3

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

Ages Eligible for Study

23 Weeks - 28 Weeks

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa Van Meurs
6507235711
Not Recruiting