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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05340465
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 3 Days
Healthy Volunteers
Not accepted

Interventions

  • Darbepoetin Alfa — DRUG
    Infants in groups 2-5 will be started on Darbe 10 mcg/kg/week between 72 and 84 hours after birth.
  • Low Molecular Weight Iron Dextran — DRUG
    Infants in groups 2 and 3 will be given LMW-ID IV, 10 or 20 mg/kg/dose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly.
  • Ferumoxytol injection — DRUG
    Infants in groups 4 and 5 will be given FMX IV, 10 or 20 mg/kg/dose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly.
  • Oral iron supplements — DRUG
    Infants in group 1 will receive standard care in the UW NICU with iron started on day 7 if tolerating 100 mL/kg/day enteral feeding. Iron supplements are adjusted every 2 weeks based on ferritin, zinc protoporphyrin to heme ratio and complete blood count (CBC).

Study Details

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

Key Dates

Start date
Nov 27, 2022
Status verified
May 2026
Primary completion
Jan 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1. Oral iron
    Oral iron is started on day 7 of life if baby is feeding 100 mL/kg/day. Iron supplements of up to 12 mg/kg/day are given based on CBC, retic, ret-hgb, serum ferritin and zinc protoporphyrin to heme ratio (ZnPP/H). Iron supplements are adjusted every 2 weeks following iron studies.
  • Experimental: Group 2
    Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 10 mg/kg x 1, retreat if ferritin \< 76 mcg/L
  • Experimental: Group 3
    Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 20 mg/kg x 1, retreat if ferritin \< 76 mcg/L
  • Experimental: Group 4
    Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 10 mg/kg x 1, retreat if ferritin \< 76 mcg/L
  • Experimental: Group 5
    Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 20 mg/kg x 1, retreat if ferritin \< 76 mcg/L

Primary Outcome Measure

Plasma Ferritin at 35-36 weeks PMA [ Time Frame: birth to 36 weeks postmenstrual age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
John Feltner, MS
[email protected]
206 616-8021
Sandra E Juul, MD, PhD (SUB_INVESTIGATOR)
Kendell R German, MD (PRINCIPAL_INVESTIGATOR)
Dennis E Mayock, MD (SUB_INVESTIGATOR)
Sarah Kolnik, MD (SUB_INVESTIGATOR)
Sara Neches, MD (SUB_INVESTIGATOR)
Katie Strobel, MD (SUB_INVESTIGATOR)

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