Actively Recruiting
Led by University of Washington · Updated on 2026-05-26
120
Participants Needed
1
Research Sites
21 weeks
Total Duration
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
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 mg/kg or 20 mg/kg). 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
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Complete this quick 3-step screening to check your eligibility
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
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
K
Kendell R German, MD
J
John Feltner, MS
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