Clinical trial 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?
An investigational injectable medicine being studied to help reduce the need for blood transfusions in premature infants. is designed to stimulate the bone marrow to produce more red blood cells.
Also referred to as Aranesp.
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
- The study wants to see if giving darbepoetin with slow‑release IV iron is safe and can reduce or eliminate transfusions, keep iron levels normal, raise blood counts, and possibly improve brain development in very preterm infants.
- Who it's for
- Infants born before 32 completed weeks of pregnancy.
- What's involved
- Participants will receive darbepoetin injections and an IV iron product (either Ferumoxytol or low‑molecular‑weight iron dextran) instead of standard oral iron, with regular clinic visits and blood tests to monitor safety and iron status.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.