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Led by University of Washington · Updated on 2026-05-26
120
Participants Needed
1
Research Sites
21 weeks
Total Duration
Researchers are evaluating a combination of darbepoetin Darbe and slow-release intravenous IV iron to reduce the need for blood transfusions, maintain iron levels, and improve brain development in preterm infants born before 32 completed weeks of gestation. This phase II trial compares two types of IV iron, Ferumoxytol FMX and low molecular weight iron dextran LMW-ID, against standard oral iron supplements. The study aims to assess safety, dosing, iron sufficiency, hematocrit levels, and neurodevelopmental outcomes, along with how these treatments affect the gut microbiome. Infants will be assigned to one of five groups standard oral iron supplements starting on day 7 if feeding well, or Darbe started between 3 and 3.5 days of life combined with either LMW-ID or FMX at two different doses 10 mgkg or 20 mgkg. Iron dosing begins at 7 days of life with adjustments based on iron levels measured every two weeks. Retreatment occurs if iron stores fall below a certain level. The study includes monitoring of adverse reactions and comparison of gastrointestinal tolerance between IV and oral iron. Participants will be followed from birth to 36 weeks postmenstrual age or discharge, with assessments of iron status, blood transfusions, and safety. Neurodevelopment will be evaluated up to 2 years of age using standardized developmental tests. Stool samples will be collected early and long-term to study the gut microbiome. The study tracks multiple outcomes including blood iron levels, transfusion frequency and volume, hematocrit, safety events, brain function tests, and developmental skills over time.
CONDITIONS
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
K
Kendell R German, MD
J
John Feltner, MS
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University of Washington
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Darbepoetin alfa plus IV iron | Oral iron (standard care) |
|---|---|---|
| What it is | Weekly darbepoetin alfa starting at 72–84 hours plus intravenous iron dosed (LMW‑ID or ferumoxytol) with re‑dosing if ferritin falls below 76 | Standard enteral iron supplementation adjusted every two weeks based on iron studies |
| Primary use in trial | Investigated to reduce blood transfusions while maintaining iron sufficiency with ESA plus IV iron | Serves as standard care comparator using oral iron to maintain iron levels |
| Evidence status | ESA plus IV iron can stimulate erythropoiesis and reduce transfusion requirements in preterm infants | Enteral iron supplementation is standard practice in preterm infants to support iron stores |
| Important risks | Safety outcomes to be assessed but specific risks of ESA or IV iron are not detailed | Not explicitly detailed in trial registry |
| Important limitations | ESA plus IV iron may pose risks such as retinopathy of prematurity or systemic iron overload not yet proven | Enteral iron supplementation may not fully prevent transfusions in very preterm infants |
| Patient impact | May reduce need for blood transfusions and improve iron sufficiency, potentially lowering donor exposure | Supporting iron stores may reduce anemia but transfusion need may persist |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - Up to 72 hours after birth
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From day 3 to 36 weeks postmenstrual age or prior to discharge
Participants receive Darbepoetin Alfa starting between 72 and 84 hours after birth. Iron supplementation begins on day 7 with either low molecular weight iron dextran, ferumoxytol injection, or oral iron supplements depending on group assignment. Iron doses are adjusted based on biweekly iron parameter checks and continued until 36 weeks postmenstrual age or prior to discharge.
Biweekly visits for iron parameter assessments and weekly Darbe dosing visits
Duration - Up to 2 years corrected age
Neurodevelopmental outcomes and stool microbiome are assessed up to 2 years of age to evaluate long-term effects of the interventions.
Visits at 3 months, 6 months, 18 months, 1 year, and 2 years corrected age
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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Sandra E Juul, Bryan A Comstock, Dennis E Mayock...
https://pubmed.ncbi.nlm.nih.gov/41430711/University of Washington
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
