Using Darbe and IV iron to reduce transfusions in preterm infants
Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants
This study is testing if giving preterm infants a combination of a special medication and intravenous iron can help reduce the need for blood transfusions and support their growth and development better than regular oral iron.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 3 Days |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05340465 on ClinicalTrials.gov |
What this trial studies
This phase II trial aims to evaluate the safety and efficacy of darbepoetin (Darbe) combined with intravenous iron formulations (Ferumoxytol or low molecular weight iron dextran) in preterm infants born before 32 weeks of gestation. The study will compare these treatments to standard oral iron supplementation to determine their impact on reducing transfusions, maintaining iron sufficiency, and improving neurodevelopmental outcomes. Participants will be monitored for adverse reactions and long-term effects on the stool microbiome. The trial will include assessments of hematocrit levels and neurodevelopmental progress up to two years of age.
Who should consider this trial
Good fit: Ideal candidates are NICU patients born between 24 and 31 weeks of gestation who require treatment for iron deficiency.
Not a fit: Patients with significant fetal or infant anomalies, high iron stores, or severe infections at enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions in preterm infants while ensuring adequate iron levels and promoting better neurodevelopment.
How similar studies have performed: Other studies have shown promise in using intravenous iron for similar populations, but this specific combination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Kendell R German, MD — University of Washington
- Study coordinator: Kendell R German, MD
- Email: germank@uw.edu
- Phone: (206)221-5716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.