Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
Recruiting
Phase 2
Interventional Study
Prematurity
Iron-deficiency
Iron Deficiency Anemia
Iron Malabsorption
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 3 Days
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- University of Washington · Other
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About This Trial
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 Dar…
Trial Locations
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Eligibility Criteria
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 ano…
Contacts