Recruiting

Phase 2

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

Sponsor:

University of Washington

Code:

NCT05340465

Conditions

Prematurity

Iron-deficiency

Iron Deficiency Anemia

Iron Malabsorption

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Darbepoetin Alfa

Low Molecular Weight Iron Dextran

Ferumoxytol injection

Oral iron supplements

Study Details

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 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

Conditions

Prematurity

Iron-deficiency

Iron Deficiency Anemia

Iron Malabsorption

Study ID

NCT05340465

Start date

Nov 27, 2022

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Darbepoetin Alfa

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

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

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

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).

Primary outcome measure

Plasma Ferritin at 35-36 weeks PMA [ Time Frame: birth to 36 weeks postmenstrual age ]
Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL [ Time Frame: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) ]
Number of Blood transfusions [ Time Frame: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) ]
Volume of blood transfusions [ Time Frame: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) ]

Central Contacts and Locations

Central contacts

Kendell R German, MD

(206)221-5716 germank@uw.edu

John Feltner, MS

206 616-8021 jfeltner@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

John Feltner, MS

206 616-8021 jfeltner@uw.edu

Principal Investigator:

Kendell R German, MD

More Information

Sponsor

University of Washington

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

prematurity
iron deficiency
anemia
darbepoetin
IV Iron

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-26.