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

Last updated: December 3, 2024
Sponsor: University of Washington
Overall Status: Active - Recruiting

Phase

2

Condition

Gastrointestinal Diseases And Disorders

Anemia

Treatment

Darbepoetin Alfa

Ferumoxytol injection

Oral iron supplements

Clinical Study ID

NCT05340465
STUDY00015143
R01HD107003
  • Ages < 3
  • All Genders

Study 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 transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes of preterm infants.

Investigators hypothesize that in infants < 32 completed weeks of gestation, combined treatment with Darbe plus Ferumoxytol (FMX) or Darbe plus low molecular weight iron dextran (LMW-ID) will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators further hypothesize that when compared to oral iron supplementation (standard care), IV iron will be better tolerated, with less effect on the gastrointestinal (GI) microbiome

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Known fetal/infant anomalies of clinical significance (brain, cardiac, chromosomalanomalies)

  • 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 withcorresponding ZnPP/H of <30, Transferrin saturation >75%, iron > 200 mcg/dL, TIBC < 100 mcg/dL)

  • Culture proven sepsis, meningitis, urinary tract infection, or other significantinfection at the time of enrollment

  • Mother under 18 years of age

  • Unable to consent in English or Spanish

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: Darbepoetin Alfa
Phase: 2
Study Start date:
November 27, 2022
Estimated Completion Date:
December 31, 2027

Study 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) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators further hypothesize that when compared to oral iron supplementation (standard care), IV iron will be better tolerated, with less effect on the gastrointestinal (GI) microbiome

Objectives:

  1. To compare the safety, dose, and dosing interval for FMX and LMW-ID required for preterm infants receiving Darbe.

    Iron dosing will begin at 7 days after birth. Initial doses of 10 mg/kg/dose or 20 mg/kg/dose will be compared for each iron formulation (N=20 each).

  2. To compare the safety, tolerance, and efficacy of IV iron (FMX or LMW-ID) plus Darbe (N=80) to standard care (oral ferrous sulfate (N=40). Adverse reactions to IV Iron will be documented, as will adverse responses to oral iron (feeding intolerance). Potential differences in the stool microbiome will be evaluated 3 weeks after the initial IV and oral iron doses.

  3. Determine long-term outcomes:

    • 3.1 Neurodevelopmental outcomes of infants enrolled in Objectives 1 and 2 (N=120) will be sequentially assessed up to 2 years of age.

    • 3.2 The stool microbiome will be compared between study groups at 12 and 24 months to determine whether mode of iron delivery has long-term effects.

Connect with a study center

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

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