Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
Launched by UNIVERSITY OF WASHINGTON · Apr 14, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a combination of two treatments—darbepoetin (Darbe) and intravenous (IV) iron—to help preterm infants who are at risk for iron deficiency and may need blood transfusions. The goal is to see if this combination can safely reduce the need for transfusions, keep the infants' iron levels healthy, and support better brain development. The trial is specifically looking at infants born before 32 weeks of gestation who are currently in the Neonatal Intensive Care Unit (NICU).
To participate in this trial, infants must be between 24 and 31 weeks old at birth and meet certain health criteria. They should not have significant health issues or infections and must have parents who can provide consent. If eligible, participants will receive either the new treatment or standard care, and researchers will monitor their health closely. This trial aims to find a better way to support the health of preterm infants and improve their overall outcomes.
Gender
ALL
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
About University Of Washington
The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
Patients applied
Trial Officials
Sandra E Juul, MD, PhD
Principal Investigator
University of Washington
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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