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Darbepoetin plus slow-release IntraVenous Iron to decrease transfusions and improve iron status and neurodevelopment
Sandra E Juul1,2, Bryan A Comstock3, Dennis E Mayock4
1Department of Pediatrics, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA. sjuul@uw.edu.
Insights
This Phase II trial investigates darbepoetin plus intravenous iron for preterm infants to reduce anemia and transfusions. The study assesses safety, efficacy, and neurodevelopmental outcomes up to two years corrected age.
Area of Science:
- Neonatal Medicine
- Hematology
- Developmental Pediatrics
Background:
- Preterm infants face high risks of anemia, iron deficiency, and transfusions, impacting neurodevelopment.
- Erythropoietic-stimulating agents and intravenous iron are potential interventions.
Purpose of the Study:
- To evaluate the safety and efficacy of darbepoetin combined with slow-release intravenous iron (ferumoxytol or low-molecular-weight iron dextran) in preterm infants.
- To determine the optimal iron preparation and dosage for maintaining iron sufficiency and reducing transfusions.
- To assess the impact of these treatments on the gut microbiome and neurodevelopment.
Main Methods:
- A randomized controlled Phase II trial involving 120 preterm infants (24-0/7 to 31-6/7 weeks gestation).
- Infants were randomized into five groups: oral iron (standard care) or weekly darbepoetin with varying doses of ferumoxytol or low-molecular-weight iron dextran.
- Outcomes include ferritin levels, hematologic assessments, drug safety, microbiome analysis, and neurodevelopmental testing up to 2 years corrected age.
Main Results:
- Primary outcome is ferritin level at 34-36 weeks postmenstrual age.
- Secondary outcomes include transfusion rates, safety, microbiome diversity, and neurodevelopmental trajectories.
- The study is ongoing, and results are pending.
Conclusions:
- This trial will provide crucial data on the safety and effectiveness of novel iron supplementation strategies in preterm infants.
- Findings will inform clinical practice regarding anemia management and its long-term effects on neurodevelopment.
- The study will elucidate the relationship between intravenous iron, gut microbiome, and neurodevelopmental outcomes.
Background:
Infants born preterm are at high risk of anemia, red blood cell transfusions, and iron deficiency, all of which may negatively influence long-term neurodevelopment. To ameliorate these complications of prematurity, we developed a Phase II trial to determine whether treatment with an erythropoietic-stimulating agent, darbepoetin (Darbe), plus a slow-release intravenous (IV) iron preparation (ferumoxytol (FMX) or low-molecular-weight iron dextran (LMW-ID)) might decrease transfusions while maintaining iron sufficiency.
Methods:
This single-center study is a parallel design, prospective, randomized controlled Phase II trial of 120 infants born 24-0/7 to 31-6/7 weeks of gestation cared for in the University of Washington Neonatal Intensive Care Unit. After informed consent, infants less than 72 h of age are randomized to one of five treatment groups: (1) Oral iron (standard care), n = 40, or weekly Darbe 10 µg/kg/dose IV or SQ plus; (2) FMX - 10 mg/kg/dose IV, n = 20; (3) FMX - 20 mg/kg/dose IV, n = 20; (4) LMW-ID - 10 mg/kg/dose IV, n = 20; or (5) LMW-ID - 20 mg/kg/dose IV, n = 20. Infants will be followed to 2-year corrected age with sequential developmental testing. Our primary outcome is ferritin level at 34-36 weeks postmenstrual age. Secondary outcomes include other hematologic assessments, drug safety, evaluation of the gut microbiome, and neurodevelopment to 2 years corrected age.
Discussion:
This trial will determine whether darbepoetin plus a slow-release IV iron preparation is safe, which iron preparation and dose best maintain iron sufficiency and decrease or eliminate transfusions, whether IV iron will result in a more diverse, less pathogenic microbiome when compared to oral iron supplementation, and, finally, whether these treatments affect neurodevelopment to 2 years corrected age.
Trial Registration:
National Clinical Trial (NCT) NCT05340465. Registered on March 1, 2022.
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