Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
Status:
Not yet recruiting
Trial end date:
2027-06-30
Target enrollment:
Participant gender:
Summary
In this phase II trial, the investigators overarching goal is to demonstrate the feasibility
and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to
decrease transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes
of preterm infants.
Investigators hypothesize that in infants < 32 completed weeks of gestation, combined
treatment with Darbe plus Ferumoxytol (FMX) or Darbe plus low molecular weight iron dextran
(LMW-ID) will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron
sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators
further hypothesize that when compared to oral iron supplementation (standard care), IV iron
will be better tolerated, with less effect on the gastrointestinal (GI) microbiome
Phase:
Phase 2
Details
Lead Sponsor:
University of Washington
Treatments:
Darbepoetin alfa Dextrans Ferrosoferric Oxide Iron Iron-Dextran Complex