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

Completed · Phase 3 · Has a placebo group

Conditions studied: Neurocognitive, Neuroprotective, Neonatal, Neurodevelopmental Impairment

In brief

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

Key facts

Study ID

NCT03169881

Run by

NICHD Neonatal Research Network

People needed

650

Starts

2017-09-20

Expected to finish

2025-05-12

Last updated by the study team

2026-07-01

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inborn and outborn preterm infants
• 23 0/7-28 6/7 weeks gestational age
• ≤24 hours postnatal age

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• Emory University — Atlanta, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• University of Rochester — Rochester, New York, United States
• RTI International — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
• Univeristy of Pennsylvania — Philadelphia, Pennsylvania, United States
• Brown University - Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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