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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

650

Participants

Timeline

Start Date

September 20, 2017

Primary Completion Date

December 23, 2022

Study Completion Date

August 31, 2028

Conditions
NeurocognitiveNeuroprotectiveNeonatalNeurodevelopmental Impairment
Interventions
DRUG

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.

DRUG

Placebo

normal saline for IV administration, or sham dosing. Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.

Trial Locations (16)

14642

University of Rochester, Rochester

19104

Univeristy of Pennsylvania, Philadelphia

27705

RTI International, Durham

27710

Duke University, Durham

30303

Emory University, Atlanta

35233

University of Alabama at Birmingham, Birmingham

43205

Research Institute at Nationwide Children's Hospital, Columbus

44106

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland

45267

Cincinnati Children's Medical Center, Cincinnati

52242

University of Iowa, Iowa City

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

77030

University of Texas Health Science Center at Houston, Houston

84108

University of Utah, Salt Lake City

87131

University of New Mexico, Albuquerque

94304

Stanford University, Palo Alto

02905

Brown University - Women and Infants Hospital of Rhode Island, Providence

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

NICHD Neonatal Research Network

NETWORK