Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
Key facts
- Who runs it
- University of Washington
- Where
- Seattle, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 120 people, planned
- Started
- 27 Nov 2022
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 5 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Darbepoetin Alfa
- Low Molecular Weight Iron Dextran
- Ferumoxytol injection
- Oral iron supplements
- Record updated
- 26 May 2026
Who can take part
- Age
- Up to 3 days
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Known fetal/infant anomalies of clinical significance (brain, cardiac, chromosomal anomalies)
- Culture proven sepsis, meningitis, urinary tract infection, or other significant infection at the time of enrollment
- Mother under 18 years of age
- Parental consent unable to be obtained by 72 hours after birth
- Central hematocrit > 65%
- Unable to consent in English or Spanish
Where in United States
- University of WashingtonSeattle, United StatesContact: John Feltner, MSTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 5 groups in the trial
- Group 1. Oral ironExisting treatment, for comparison
Oral iron is started on day 7 of life if baby is feeding 100 mL/kg/day. Iron supplements of up to 12 mg/kg/day are given based on CBC, retic, ret-hgb, serum ferritin and zinc protoporphyrin to heme ratio (ZnPP/H). Iron supplements are adjusted every 2 weeks following iron studies.
Treatment: Oral iron supplements
- Group 2Treatment being tested
Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 10 mg/kg x 1, retreat if ferritin \< 76 mcg/L
Treatment: Darbepoetin Alfa and Low Molecular Weight Iron Dextran
- Group 3Treatment being tested
Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 20 mg/kg x 1, retreat if ferritin \< 76 mcg/L
Treatment: Darbepoetin Alfa and Low Molecular Weight Iron Dextran
- Group 4Treatment being tested
Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 10 mg/kg x 1, retreat if ferritin \< 76 mcg/L
Treatment: Darbepoetin Alfa and Ferumoxytol injection
- Group 5Treatment being tested
Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 20 mg/kg x 1, retreat if ferritin \< 76 mcg/L
Treatment: Darbepoetin Alfa and Ferumoxytol injection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants
- Publications
- Record updated
- 26 May 2026