Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 27, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
PrematurityIron-deficiencyIron Deficiency AnemiaIron Malabsorption
Interventions
DRUG

Darbepoetin Alfa

Infants in groups 2-5 will be started on Darbe 10 mcg/kg/week between 72 and 84 hours after birth.

DRUG

Low Molecular Weight Iron Dextran

Infants in groups 2 and 3 will be given LMW-ID IV, 10 or 20 mg/kg/dose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly.

DRUG

Ferumoxytol injection

Infants in groups 4 and 5 will be given FMX IV, 10 or 20 mg/kg/dose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly.

DRUG

Oral iron supplements

Infants in group 1 will receive standard care in the UW NICU with iron started on day 7 if tolerating 100 mL/kg/day enteral feeding. Iron supplements are adjusted every 2 weeks based on ferritin, zinc protoporphyrin to heme ratio and complete blood count (CBC).

Trial Locations (1)

98195

RECRUITING

University of Washington, Seattle

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Washington

OTHER