Status:
RECRUITING
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Prematurity
Iron-deficiency
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE2
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 transfusio...
Detailed Description
Investigators hypothesize that in infants \< 32 completed weeks of gestation, combined treatment with Darbe plus FMX or Darbe plus LMW-ID will: 1) be safe, 2) decrease or eliminate transfusions, 3) ma...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
November 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05340465
Start Date
November 27 2022
End Date
June 30 2027
Last Update
November 28 2025
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195