RecruitingPhase 2

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

United States120 participantsStarted 2022-11-27

Plain-language 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

Who can participate

Age range

3 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma Ferritin at 35-36 weeks PMA

Timeframe: birth to 36 weeks postmenstrual age

Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL

Timeframe: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

Number of Blood transfusions

Timeframe: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

Volume of blood transfusions

Timeframe: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

Trial details

NCT IDNCT05340465

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-30

Contact for this trial

Kendell R German, MD

(206)221-5716 germank@uw.edu

View on ClinicalTrials.gov More Prematurity trials

Plain-language summary

Who can participate

Age range

3 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Plasma Ferritin at 35-36 weeks PMA

Timeframe: birth to 36 weeks postmenstrual age

Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL

Timeframe: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

Number of Blood transfusions

Timeframe: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

Volume of blood transfusions

Timeframe: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)