Trial of darbepoetin plus slow-release intravenous iron to decrease transfusions and improve iron status and neurodevelopment in preterm infants
DIVI Trial
What is the goal of the study?
In this phase II trial, our 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. We hypothesize that in infants < 32 completed weeks of gestation, combined treatment with Darbe plus ferumoxytol or Darbe plus low molecular weight iron dextran will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. We 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.
Who can participate in the study?
Please contact the study team listed below to learn more.