Darbe Administration in Newborns Undergoing Cooling for Encephalopathy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Hypoxic Ischemic Encephalopathy
Interventions
DRUG

Darbepoetin alfa

10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old.

DRUG

Darbepoetin alfa

2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old.

DRUG

Placebo

Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old

Trial Locations (7)

84108

University of Utah, Salt Lake City

84132

Primary Children's Hospital, Salt Lake City

84403

McKay Dee Hospital- Intermountain Healthcare, Ogden

841074

Intermountain Medical Center, Sandy City

87131-0001

University of New Mexico, Albuquerque

37232-9544

Vanderbilt University School of Medicine, Nashville

98195-6320

University of Washington, Seattle

All Listed Sponsors
collaborator

Thrasher Research Fund

OTHER

lead

University of Utah

OTHER

NCT01471015 - Darbe Administration in Newborns Undergoing Cooling for Encephalopathy | Biotech Hunter | Biotech Hunter