RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-11-27
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05340465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 3 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Known fetal/infant anomalies of clinical significance (brain, cardiac, chromosomal anomalies)
  2. * Parental consent unable to be obtained by 72 hours after birth
  3. * Central hematocrit \> 65%
  4. * 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)
  5. * Culture proven sepsis, meningitis, urinary tract infection, or other significant infection at the time of enrollment
  6. * Mother under 18 years of age
  7. * Unable to consent in English or Spanish

Contacts and Locations

Study Contact

Sandra E Juul, MD, PhD
CONTACT
425 246-2536
sjuul@uw.edu
John Feltner, MS
CONTACT
206 616-8021
jfeltner@uw.edu

Principal Investigator

Sandra E Juul, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Sandra E Juul, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-27
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-11-27
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • prematurity
  • iron deficiency
  • anemia
  • darbepoetin
  • IV Iron

Additional Relevant MeSH Terms

  • Prematurity
  • Iron-deficiency
  • Iron Deficiency Anemia
  • Iron Malabsorption