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

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Darbepoetin alfa

Criteria

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