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

NICHD-NRN-0058

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

2017-09-20

2022-12-23

2028-08-01

Active (not recruiting)

Early phase I

650

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, masked, placebo-controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Primary providers and bedside caregivers will be blinded to randomization group. If the dose will be administered IV, the study drug will be administered slow IV push by the bedside nurse. If the dose will be administered subcutaneously, the study drug will be brought to the bedside in a closed container, and injections will be shielded behind screens and out of earshot from caregivers and parents. An adhesive bandage (or 2x2 gauze) will be placed over the true and sham injection sites and either taped or held in place until no evidence of the injection is visible. The parents, medical providers, data collection staff and neurodevelopmental follow up personnel will be masked to the treatment arm.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 650, 'type': 'ACTUAL'}}

2023-12-12