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Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Sponsor: NICHD Neonatal Research Network
Summary
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
Key Details
Gender
All
Age Range
1 Hour - 24 Hours
Study Type
INTERVENTIONAL
Enrollment
650
Start Date
2017-09-20
Completion Date
2025-05-12
Last Updated
2026-07-01
Healthy Volunteers
No
Interventions
Darbepoetin
Darbepoetin 10 micrograms/kg/once every week (IV or SC). Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.
Placebo
normal saline for IV administration, or sham dosing. Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.
Locations (16)
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