PrematurityPhase 2DIVINCT05340465
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
A Phase 2 study testing Darbepoetin Alfa, Low Molecular Weight Iron Dextran and Ferumoxytol injection in people with Prematurity and Iron-deficiency, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Prematurity, Iron-deficiency, Iron Deficiency Anemia
- What is being tested?
- Darbepoetin Alfa, Low Molecular Weight Iron Dextran and Ferumoxytol injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2022to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 <30, Transferrin saturation >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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
John Feltner, MS, 206 616-8021, jfeltner@uw.edu
Sandra E Juul, MD, PhD
About this study
Official title: Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants
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
Read the detailed description
Investigators hypothesize that in infants < 32 completed weeks of gestation, combined treatment with Darbe plus FMX or Darbe plus 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
Objectives:
- To compare the safety, dose, and dosing interval for FMX and LMW-ID required for preterm infants receiving Darbe. Iron dosing will begin at 7 days after birth. Initial doses of 10 mg/kg/dose or 20 mg/kg/dose will be compared for each iron formulation (N=20 each).
- To compare the safety, tolerance, and efficacy of IV iron (FMX or LMW-ID) plus Darbe (N=80) to standard care (oral ferrous sulfate (N=40). Adverse reactions to IV Iron will be documented, as will adverse responses to oral iron (feeding intolerance). Potential differences in the stool microbiome will be evaluated 3 weeks after the initial IV and oral iron doses.
- Determine long-term outcomes:
- 3.1 Neurodevelopmental outcomes of infants enrolled in Objectives 1 and 2 (N=120) will be sequentially assessed up to 2 years of age.
- 3.2 The stool microbiome will be compared between study groups at 12 and 24 months to determine whether mode of iron delivery has long-term effects.
- Being tested
- Darbepoetin Alfa, Low Molecular Weight Iron Dextran, Ferumoxytol injection, Oral iron supplements
- Keywords
- prematurity, iron deficiency, anemia, darbepoetin, IV Iron
- Medical subject headings
- Premature Birth, Anemia, Iron-Deficiency, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin AlfaDrug
Also called Aranesp, Darbe
Infants in groups 2-5 will be started on Darbe 10 mcg/kg/week between 72 and 84 hours after birth.
Low Molecular Weight Iron DextranDrug
Also called INFeD, LMW-ID
Infants in groups 2 and 3 will be given LMW-ID IV, 10 or 20 mg/kg/dose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly.
Ferumoxytol injectionDrug
Also called Feraheme, FMX
Infants in groups 4 and 5 will be given FMX IV, 10 or 20 mg/kg/dose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly.
Oral iron supplementsDrug
Also called Ferr-in-sol
Infants in group 1 will receive standard care in the UW NICU with iron started on day 7 if tolerating 100 mL/kg/day enteral feeding. Iron supplements are adjusted every 2 weeks based on ferritin, zinc protoporphyrin to heme ratio and complete blood count (CBC).
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Oral iron | Active comparator | Oral iron is started on day 7 of life if baby is feeding 100 mL/kg/day. Iron supplements of up to 12 mg/kg/day are given based on CBC, retic, ret-hgb, serum ferritin and zinc protoporphyrin to heme ratio (ZnPP/H). Iron supplements are adjusted every 2 weeks following iron studies. Receives: Drug: Oral iron supplements |
| Group 2 | Experimental | Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 10 mg/kg x 1, retreat if ferritin < 76 mcg/L Receives: Drug: Darbepoetin Alfa; Drug: Low Molecular Weight Iron Dextran |
| Group 3 | Experimental | Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 20 mg/kg x 1, retreat if ferritin < 76 mcg/L Receives: Drug: Darbepoetin Alfa; Drug: Low Molecular Weight Iron Dextran |
| Group 4 | Experimental | Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 10 mg/kg x 1, retreat if ferritin < 76 mcg/L Receives: Drug: Darbepoetin Alfa; Drug: Ferumoxytol injection |
| Group 5 | Experimental | Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 20 mg/kg x 1, retreat if ferritin < 76 mcg/L Receives: Drug: Darbepoetin Alfa; Drug: Ferumoxytol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Ferritin at 35-36 weeks PMA
Plasma ferritin is measured every 2 weeks in the NICU. Ferritin at 35-36 weeks will be compared between the 5 treatment groups
Measured: birth to 36 weeks postmenstrual age
Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL
Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL will be compared in the 4 IV treatment arms
Measured: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
Number of Blood transfusions
The number of blood transfusions received by infants in each group will be compared.
Measured: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
Volume of blood transfusions
The volume of blood transfused to infants in each group will be compared
Measured: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
Secondary outcomes (10)
Number and percent of patients per group that remain transfusion free
Number and percent of patients per group that remain transfusion free will be compared by group
Measured: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
Hematocrit
Hematocrit (lowest, highest, mean) by group to 35-36 weeks PMA
Measured: Birth to 36 weeks PMA
Safety of IV iron
Any evidence of anaphylaxis will be documented during and after the first IV infusion of iron
Measured: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
Early gut microbiome comparison between study groups
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.
Measured: at 7 days (prior to iron supplementation) and 4 weeks after birth
Rate of referral for Brainstem auditory evoked response
Any latency in Brainstem auditory evoked response will be assessed and compared between study arms
Measured: at hospital discharge, near 36 weeks postmenstrual age
Rate of pass/fail the General Movements Assessments (GMA)
General Movements Assessments (GMA) will be assessed at 3 months corrected age, and results compared between study arms.
Measured: 3 months corrected age
Scores for the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be compared between groups
Parent questionnaire (WIDEA-FS) to assess neurodevelopment will be done at 6 months corrected age. Mean and median scores will be compared by treatment arm. The WIDEA includes 50 items with a maximum score of 200. Higher scores indicate more advanced neurodevelopmental functioning.
Measured: 6 months corrected age
Scores for the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be compared between groups
Parent questionnaire (WIDEA-FS) to assess neurodevelopment will be done at 6 months corrected age. Mean and median scores will be compared by treatment arm. The WIDEA includes 50 items with a maximum score of 200. Higher scores indicate more advanced neurodevelopmental functioning.
Measured: 18 months corrected age
Late gut microbiome comparison between study groups
Stool samples will be collected for 16S amplicon sequencing and targeted culturomics. Organism types will be compared between groups. If differences in early microbiome (at 4 weeks of age) are noted, we will evaluate whether they persist at 1 and 2 years of age.
Measured: at 1 and 2 years corrected age.
Neurodevelopmental outcome as assessed by the Bayley Scales of Infant Development edition-IV (BSID-IV)
Bayley Scales of Infant Development edition-IV (BSID-IV) will be assessed in all enrolled patients at one and two years corrected age. Results for the treatment arms will be compared.
Measured: 1 year and 2 years corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start27 Nov 2022
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group 1 Control, oral iron up to 12 mg/kg/day per Unit protocol * Group 2 Darbe 10 mcg/kg q week plus LMW-ID: 10 mg/kg x 1, retreat if ferritin \< 76 mcg/L * Group 3 Darbe 10 mcg/kg q week plus LMW-ID: 20 mg/kg x 1, retreat if ferritin \< 76 mcg/L * Group 4 Darbe 10 mcg/kg q week plus FMX 10 mg/kg x 1, retreat if ferritin \< 76 mcg/L * Group 5 Darbe 10 mcg/kg q week plus FMX 20 mg/kg x 1, retreat if ferritin \< 76 mcg/L
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kendell German, University of Washington
- Investigators
- Kendell R German, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340465
- Sponsor's protocol ID
- STUDY00015143
- Other IDs
- R01HD107003
- Acronym
- DIVI
- Status last verified
- May 2026
- First submitted
- 1 Mar 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will comply with and share data in accordance with the definitions contained in the guidance document: Data Element Definitions for Interventional and Observational Studies (https://prsinfo.clinicaltrials.gov/results\_definitions.html) and the final rule (42 CFR Part 11) . In addition, we will comply with NICHD requirements to release our de-identified data-set to the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access data from studies funded by NICHD after the acceptance of publication of our main findings of the final data set (2 year outcomes) as per the NIH Data Sharing Policy: https://dash.nichd.nih.gov/. Biospecimens will not be available. Data will include study protocol, CRFs, and collected, de-identified data collected in REDCap.
Publications
Juul SE, Comstock BA, Mayock DE, German K, Feltner J, Irvine J, Lagerquist E, Heagerty PJ. 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. Trials. 2025 Dec 22;26(1):590. doi: 10.1186/s13063-025-09374-9.
PubMed 41430711
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants
- ClinicalTrials.gov ID
- NCT05340465
- Acronym / sponsor ID
- DIVI / STUDY00015143
- Keywords
- prematurity, iron deficiency, anemia, darbepoetin, IV Iron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 27 Nov 2022 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Investigators hypothesize that in infants < 32 completed weeks of gestation, combined treatment with Darbe plus FMX or Darbe plus 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
Objectives:
- To compare the safety, dose, and dosing interval for FMX and LMW-ID required for preterm infants receiving Darbe. Iron dosing will begin at 7 days after birth. Initial doses of 10 mg/kg/dose or 20 mg/kg/dose will be compared for each iron formulation (N=20 each).
- To compare the safety, tolerance, and efficacy of IV iron (FMX or LMW-ID) plus Darbe (N=80) to standard care (oral ferrous sulfate (N=40). Adverse reactions to IV Iron will be documented, as will adverse responses to oral iron (feeding intolerance). Potential differences in the stool microbiome will be evaluated 3 weeks after the initial IV and oral iron doses.
- Determine long-term outcomes:
- 3.1 Neurodevelopmental outcomes of infants enrolled in Objectives 1 and 2 (N=120) will be sequentially assessed up to 2 years of age.
- 3.2 The stool microbiome will be compared between study groups at 12 and 24 months to determine whether mode of iron delivery has long-term effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- * Group 1 Control, oral iron up to 12 mg/kg/day per Unit protocol * Group 2 Darbe 10 mcg/kg q week plus LMW-ID: 10 mg/kg x 1, retreat if ferritin < 76 mcg/L * Group 3 Darbe 10 mcg/kg q week plus LMW-ID: 20 mg/kg x 1, retreat if ferritin < 76 mcg/L * Group 4 Darbe 10 mcg/kg q week plus FMX 10 mg/kg x 1, retreat if ferritin < 76 mcg/L * Group 5 Darbe 10 mcg/kg q week plus FMX 20 mg/kg x 1, retreat if ferritin < 76 mcg/L
| Arm | Type | Receives |
|---|---|---|
| Group 1. Oral iron | Active comparator | Drug: Oral iron supplementsOral iron is started on day 7 of life if baby is feeding 100 mL/kg/day. Iron supplements of up to 12 mg/kg/day are given based on CBC, retic, ret-hgb, serum ferritin and zinc protoporphyrin to heme ratio (ZnPP/H). Iron supplements are adjusted every 2 weeks following iron studies. |
| Group 2 | Experimental | Drug: Darbepoetin Alfa, Drug: Low Molecular Weight Iron DextranInfants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 10 mg/kg x 1, retreat if ferritin < 76 mcg/L |
| Group 3 | Experimental | Drug: Darbepoetin Alfa, Drug: Low Molecular Weight Iron DextranInfants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 20 mg/kg x 1, retreat if ferritin < 76 mcg/L |
| Group 4 | Experimental | Drug: Darbepoetin Alfa, Drug: Ferumoxytol injectionInfants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 10 mg/kg x 1, retreat if ferritin < 76 mcg/L |
| Group 5 | Experimental | Drug: Darbepoetin Alfa, Drug: Ferumoxytol injectionInfants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 20 mg/kg x 1, retreat if ferritin < 76 mcg/L |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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 <30, Transferrin saturation >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin AlfaAlso: Aranesp, DarbeInfants in groups 2-5 will be started on Darbe 10 mcg/kg/week between 72 and 84 hours after birth. | Drug | Group 2, Group 3, Group 4, Group 5 |
| Low Molecular Weight Iron DextranAlso: INFeD, LMW-IDInfants in groups 2 and 3 will be given LMW-ID IV, 10 or 20 mg/kg/dose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly. | Drug | Group 2, Group 3 |
| Ferumoxytol injectionAlso: Feraheme, FMXInfants in groups 4 and 5 will be given FMX IV, 10 or 20 mg/kg/dose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly. | Drug | Group 4, Group 5 |
| Oral iron supplementsAlso: Ferr-in-solInfants in group 1 will receive standard care in the UW NICU with iron started on day 7 if tolerating 100 mL/kg/day enteral feeding. Iron supplements are adjusted every 2 weeks based on ferritin, zinc protoporphyrin to heme ratio and complete blood count (CBC). | Drug | Group 1. Oral iron |
Primary outcome
Plasma Ferritin at 35-36 weeks PMA
Time frame: 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
Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL
Time frame: 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
Number of Blood transfusions
Time frame: 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.
Volume of blood transfusions
Time frame: 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
10 secondary outcomes
Number and percent of patients per group that remain transfusion free
Time frame: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
Hematocrit
Time frame: Birth to 36 weeks PMA
Safety of IV iron
Time frame: Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
Early gut microbiome comparison between study groups
Time frame: at 7 days (prior to iron supplementation) and 4 weeks after birth
Rate of referral for Brainstem auditory evoked response
Time frame: at hospital discharge, near 36 weeks postmenstrual age
Rate of pass/fail the General Movements Assessments (GMA)
Time frame: 3 months corrected age
Scores for the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be compared between groups
Time frame: 6 months corrected age
Scores for the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be compared between groups
Time frame: 18 months corrected age
Late gut microbiome comparison between study groups
Time frame: at 1 and 2 years corrected age.
Neurodevelopmental outcome as assessed by the Bayley Scales of Infant Development edition-IV (BSID-IV)
Time frame: 1 year and 2 years corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Derived from this study: PubMed 41430711Juul SE, Comstock BA, Mayock DE, German K, Feltner J, Irvine J, Lagerquist E, Heagerty PJ. 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. Trials. 2025 Dec 22;26(1):590. doi: 10.1186/s13063-025-09374-9.
- Individual participant dataSharing planned: Yes. We will comply with and share data in accordance with the definitions contained in the guidance document: Data Element Definitions for Interventional and Observational Studies (https://prsinfo.clinicaltrials.gov/results_definitions.html) and the final rule (42 CFR Part 11) . In addition, we will comply with NICHD requirements to release our de-identified data-set to the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access data from studies funded by NICHD after the acceptance of publication of our main findings of the final data set (2 year outcomes) as per the NIH Data Sharing Policy: https://dash.nichd.nih.gov/. Biospecimens will not be available. Data will include study protocol, CRFs, and collected, de-identified data collected in REDCap.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kendell R German, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darbepoetin Alfa, Low Molecular Weight Iron Dextran and Ferumoxytol injection in people with Prematurity and Iron-deficiency, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kendell R German, MD ((206)221-5716, germank@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Ferritin at 35-36 weeks PMA (time frame: birth to 36 weeks postmenstrual age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05340465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.