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

RecruitingPhase 2Ages any - 3 DaysAllUniversity of Washington
NCT05340465 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: • NICU patients (male and female) born at 24-0/7 to 31-6/7 weeks of gestation All patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences. Exclusion Criteria: * Known fetal/infant anomalies of clinical significance (brain, cardiac, chromosomal anomalies) * Parental consent unable to be obtained by 72 hours after birth * Central hematocrit \> 65% * Evidence of high iron stores prior to enrollment (e.g. Ferritin \>400 ng/mL with corresponding ZnPP/H of \<30, Transferrin saturation \>75%, iron \> 200 mcg/dL, TIBC \< 100 mcg/dL) * Culture proven sepsis, meningitis, urinary tract infection, or other significant infection at the time of enrollment * Mother under 18 years of age * Unable to consent in English or Spanish
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What it tests

  • Darbepoetin Alfa
  • Low Molecular Weight Iron Dextran
  • Ferumoxytol injection
  • Oral iron supplements
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Where

1 site
University of Washington
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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