RecruitingPhase 2NCT05340465

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

Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants

Sponsor

University of Washington

Enrollment

120 participants

Start Date

Nov 27, 2022

Study Type

INTERVENTIONAL

Conditions

Iron-Deficiency Anemia Iron-deficiency Prematurity Iron Malabsorption

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

Eligibility

Max Age: 3 Days

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a drug called darbepoetin (Darbe) with intravenous iron can reduce the need for blood transfusions in very premature babies while keeping their iron levels healthy. Premature infants often develop anemia because their bodies cannot yet produce enough red blood cells. You may be eligible if... - Your baby was born between 24 and 32 weeks of gestational age - Your baby is currently in the NICU - Parental consent can be obtained within 72 hours of birth You may NOT be eligible if... - Your baby has a known significant brain, heart, or chromosomal abnormality - Your baby already has very high iron stores - Your baby has an active serious infection (sepsis, meningitis, etc.) at the time of enrollment - The mother is under 18 years of age - Consent cannot be provided in English or Spanish Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDarbepoetin Alfa

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

DRUGLow 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.

DRUGFerumoxytol 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.

DRUGOral 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).

Locations(1)

University of Washington

Seattle, Washington, United States

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NCT05340465

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