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New treatment option for Prematurity
Official title Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
ClinicalTrials.gov ID: NCT05340465
What this study is testing
What is Darbepoetin Alfa?
Darbepoetin Alfa is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prematurity.
Also referred to as Aranesp, Darbe.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 3
You may be able to join if
- NICU patients (male and female) born at 24-0/7 to 31-6/7 weeks of gestation
- All patients who meet will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.
You likely can't join if
- 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 \ 75%, iron \> 200 mcg/dL, TIBC \< 100...
- Culture proven sepsis, meningitis, urinary tract infection, or other significant infection at the time of enrollment
- Mother under 18 years of age
See the full eligibility criteria
- NICU patients (male and female) born at 24-0/7 to 31-6/7 weeks of gestation
- All patients who meet will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 3 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.