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Darbepoetin Alfa and IV Iron for Preterm Infants

This study is looking at ways to reduce the need for blood transfusions and maintain healthy iron levels in preterm infants (babies born early, between 24 and 31 weeks of pregnancy). Researchers are testing if a combination of Darbepoetin Alfa (Darbe), a medication that helps the body make red blood cells, and different types of intravenous (IV) iron (Low Molecular Weight Iron Dextran or Ferumoxytol injection) is safer and more effective than standard oral iron supplements. The study aims to see if these treatments can decrease transfusions, keep iron levels sufficient, and potentially improve brain development in these vulnerable infants. Infants aged 0-3 days can participate if they meet the inclusion criteria.

Study design
This is an interventional study planning to enroll 120 preterm infants. Infants will be divided into groups receiving Darbe plus different IV iron formulations, or standard oral iron supplements.
What's involved
Infants in the study will receive Darbe and/or IV iron or oral iron supplements. Iron levels and other blood tests will be checked regularly, and adverse reactions will be monitored.
Compensation
Not stated in the trial record.
Follow-up
Neurodevelopmental outcomes of infants will be assessed sequentially up to 2 years of age.

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NCT05340465

Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants

Recruiting
PHASE2Up to 3InterventionalTreatment
University of Washington
~120 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Darbepoetin AlfaLow Molecular Weight Iron DextranFerumoxytol injectionOral iron supplements

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma Ferritin at 35-36 weeks PMA
Measured over birth to 36 weeks postmenstrual age
+3 more outcomes measured

Conditions

Prematurity
Iron-deficiency
Iron Deficiency Anemia
Iron Malabsorption

Explore related trials

Iron-Deficiency AnemiaPreterm Birth

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Kendell R German, MD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Kendell R German, MD
[email protected]
(206)221-5716
Email the study team

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Eligibility criteria

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

What this trial measures

  • Plasma Ferritin at 35-36 weeks PMAbirth to 36 weeks postmenstrual age

    Plasma ferritin is measured every 2 weeks in the NICU. Ferritin at 35-36 weeks will be compared between the 5 treatment groups

  • Number of IV iron doses required to maintain a ferritin level of > 75 ng/mLBirth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

    Number of IV iron doses required to maintain a ferritin level of \> 75 ng/mL will be compared in the 4 IV treatment arms

  • Number of Blood transfusionsBirth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

    The number of blood transfusions received by infants in each group will be compared.

  • Volume of blood transfusionsBirth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

    The volume of blood transfused to infants in each group will be compared