NCT05340465 Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
| NCT ID | NCT05340465 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Washington |
| Condition | Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-11-27 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2022-11-27 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: • 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. Exclusion Criteria: * Known fetal/infant anomalies of clinical significance (brain, cardiac, chromosomal anomalies) * Parental consent unable to be obtained by 72 hours after birth * Central hematocrit \> 65% * 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) * Culture proven sepsis, meningitis, urinary tract infection, or other significant infection at the time of enrollment * Mother under 18 years of age * Unable to consent in English or Spanish
Contact & Investigator
Kendell R German, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05340465 clinical trial?
This trial is open to participants of all sexes, up to 3 Days, studying Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05340465 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05340465 currently recruiting?
Yes, NCT05340465 is actively recruiting participants. Contact the research team at germank@uw.edu for enrollment information.
Where is the NCT05340465 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05340465 clinical trial?
NCT05340465 is sponsored by University of Washington. The principal investigator is Kendell R German, MD at University of Washington. The trial plans to enroll 120 participants.