Evidence map›Paper›PMID 41430711›Full record

ArticleTrials2025

Darbepoetin plus slow-release IntraVenous Iron to decrease transfusions and improve iron status and neurodevelopment in preterm infants (DIVI): study protocol for a randomized, blinded phase II trial.

Sandra E Juul, Bryan A Comstock, Dennis E Mayock, Kendell German, John Feltner, Jill Irvine, Eliza Lagerquist, Patrick J Heagerty

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05340465 (Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05340465 phase2recruitingnot on this map

Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants

TypeinterventionalSponsorUniversity of WashingtonRan2022 to 2027Enrolled120ConditionsPrematurity, Iron-deficiency, Iron Deficiency Anemia, Iron MalabsorptionArmsDarbepoetin Alfa, Low Molecular Weight Iron Dextran, Ferumoxytol injection, Oral iron supplements
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Sandra E JuulDepartment of Pediatrics, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA. sjuul@uw.edu.ORCID http://orcid.org/0000-0002-6861-6229
Bryan A ComstockDepartment of Biostatistics, University of Washington, UW Tower, 15th Floor, 4333 Brooklyn Avenue NE, Seattle, WA, 98105, USA.
Dennis E MayockDepartment of Pediatrics, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
Kendell GermanDepartment of Pediatrics, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
John FeltnerDepartment of Pediatrics, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
Jill IrvineClinical Nutrition Department, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
Eliza LagerquistClinical Nutrition Department, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
Patrick J HeagertyDepartment of Biostatistics, University of Washington, UW Tower, 15th Floor, 4333 Brooklyn Avenue NE, Seattle, WA, 98105, USA.

Funding

Trial of Darbepoetin plus slow-release intravenous iron to decrease transfusions and improve iron status and neurodevelopment in preterm infantsR01HD107003 · NICHD · UNIVERSITY OF WASHINGTON · PI KENDELL GERMAN · 2022 to 2026
$2.6M
National Institute of Child Health and Human Development R01HD107003NICHD NIH HHS R01 HD107003
6 · The paper itself

Abstract

backgroundInfants born preterm are at high risk of anemia, red blood cell transfusions, and iron deficiency, all of which may negatively influence long-term neurodevelopment. To ameliorate these complications of prematurity, we developed a Phase II trial to determine whether treatment with an erythropoietic-stimulating agent, darbepoetin (Darbe), plus a slow-release intravenous (IV) iron preparation (ferumoxytol (FMX) or low-molecular-weight iron dextran (LMW-ID)) might decrease transfusions while maintaining iron sufficiency.

methodsThis single-center study is a parallel design, prospective, randomized controlled Phase II trial of 120 infants born 24-0/7 to 31-6/7 weeks of gestation cared for in the University of Washington Neonatal Intensive Care Unit. After informed consent, infants less than 72 h of age are randomized to one of five treatment groups: (1) Oral iron (standard care), n = 40, or weekly Darbe 10 µg/kg/dose IV or SQ plus; (2) FMX - 10 mg/kg/dose IV, n = 20; (3) FMX - 20 mg/kg/dose IV, n = 20; (4) LMW-ID - 10 mg/kg/dose IV, n = 20; or (5) LMW-ID - 20 mg/kg/dose IV, n = 20. Infants will be followed to 2-year corrected age with sequential developmental testing. Our primary outcome is ferritin level at 34-36 weeks postmenstrual age. Secondary outcomes include other hematologic assessments, drug safety, evaluation of the gut microbiome, and neurodevelopment to 2 years corrected age. DISCUSSION: This trial will determine whether darbepoetin plus a slow-release IV iron preparation is safe, which iron preparation and dose best maintain iron sufficiency and decrease or eliminate transfusions, whether IV iron will result in a more diverse, less pathogenic microbiome when compared to oral iron supplementation, and, finally, whether these treatments affect neurodevelopment to 2 years corrected age.

trial registrationNational Clinical Trial (NCT) NCT05340465. Registered on March 1, 2022.

Indexed as

Anemia, Iron-DeficiencyChild DevelopmentDarbepoetin alfaErythrocyte TransfusionHematinicsInfant, PrematureIronAdministration, IntravenousClinical Trials, Phase II as TopicDelayed-Action PreparationsFemaleHumansInfant, NewbornMaleProspective StudiesRandomized Controlled Trials as TopicDarbepoetin alfaDelayed-Action PreparationsHematinicsIronAnemiaDarbepoetinIron deficiencyIV ironPrematurityRed blood cell transfusions

Identifiers

PMID41430711
PMCPMC12751801

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.