At a glance
ClinicalIndex Comparison Record- ✓NICU patients born at 24-0/7 to 31-6/7 weeks of gestation
- ✓Approached without regard to sex, race, ethnicity, or religious preferences
- ✕Known fetal/infant anomalies of clinical significance (brain, cardiac, chromosomal)
- ✕Parental consent unable to be obtained by 72 hours after birth
- ✕Central hematocrit >65%
- ✕Evidence of high iron stores (Ferritin >400 ng/mL with ZnPP/H <30, Transferrin saturation >75%, iron >200 mcg/dL, or TIBC <100 mcg/dL)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants
In Brief
A Phase 2 clinical trial evaluating Darbepoetin Alfa, Low Molecular Weight Iron Dextran, and 2 other interventions for Prematurity and 3 related conditions. Currently recruiting, targeting 120 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
Infants in groups 2-5 will be started on Darbe 10 mcg/kg/week between 72 and 84 hours after birth.
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.
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.
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).