Using Darbe and IV iron to reduce transfusions in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.