Trial · NCT05340465
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
NCT05340465, Phase 2, Recruiting, University of Washington
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants. Trials, record NCT05340465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05340465
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
- NCT number
- NCT05340465
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- University of Washington
- Conditions
- Prematurity, Iron-deficiency, Iron Deficiency Anemia, Iron Malabsorption
- Interventions
- Darbepoetin Alfa, Low Molecular Weight Iron Dextran, Ferumoxytol injection, Oral iron supplements
- First posted
- 2022-04-22
- Last updated
- 2026-05-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Ferritin at 35-36 weeks PMA | birth to 36 weeks postmenstrual age | Plasma ferritin is measured every 2 weeks in the NICU. Ferritin at 35-36 weeks will be compared between the 5 treatment groups |
| Primary | Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | Number of IV iron doses required to maintain a ferritin level of \> 75 ng/mL will be compared in the 4 IV treatment arms |
| Primary | Number of Blood transfusions | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | The number of blood transfusions received by infants in each group will be compared. |
| Primary | Volume of blood transfusions | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | The volume of blood transfused to infants in each group will be compared |
| Secondary | Number and percent of patients per group that remain transfusion free | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | Number and percent of patients per group that remain transfusion free will be compared by group |
| Secondary | Hematocrit | Birth to 36 weeks PMA | Hematocrit (lowest, highest, mean) by group to 35-36 weeks PMA |
| Secondary | Safety of IV iron | Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks) | Any evidence of anaphylaxis will be documented during and after the first IV infusion of iron |
| Secondary | Early gut microbiome comparison between study groups | at 7 days (prior to iron supplementation) and 4 weeks after birth | Stool samples will be collected for 16S amplicon sequencing and targeted culturomics. Organism types will be compared between groups prior to and 3 weeks after the first IV iron dose. |
| Secondary | Rate of referral for Brainstem auditory evoked response | at hospital discharge, near 36 weeks postmenstrual age | Any latency in Brainstem auditory evoked response will be assessed and compared between study arms |
| Secondary | Rate of pass/fail the General Movements Assessments (GMA) | 3 months corrected age | General Movements Assessments (GMA) will be assessed at 3 months corrected age, and results compared between study arms. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41430711 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD107003 | Trial of Darbepoetin plus slow-release intravenous iron to decrease transfusions and improve iron status and neurodevelopment in preterm infants | GERMAN, KENDELL | UNIVERSITY OF WASHINGTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2022 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05340465
GET https://conductscience.org/api/trials/v1/NCT05340465/registered