Health TrialsbyHealthPanel

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

ConditionsPrematurityIron-deficiencyIron Deficiency AnemiaIron Malabsorption
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 3
SponsorUniversity of Washington

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 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Darbepoetin Alfa

    Drug

    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 Dextran

    Drug

    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 injection

    Drug

    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 supplements

    Drug

    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).

Treatment groups

120 Participants
are divided into 5 treatment groups
Group A: Group 1. Oral ironActive comparator 1 intervention
Group B: Group 2Experimental treatment 2 interventions
Group C: Group 3Experimental treatment 2 interventions
Group D: Group 4Experimental treatment 2 interventions
Group E: Group 5Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
birth to 36 weeks postmenstrual age
2

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

Time frame
Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
3

Number of Blood transfusions

The number of blood transfusions received by infants in each group will be compared.

Time frame
Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
4

Volume of blood transfusions

The volume of blood transfused to infants in each group will be compared

Time frame
Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)

Secondary outcomes

1

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

Time frame
Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
2

Hematocrit

Hematocrit (lowest, highest, mean) by group to 35-36 weeks PMA

Time frame
Birth to 36 weeks PMA
3

Safety of IV iron

Any evidence of anaphylaxis will be documented during and after the first IV infusion of iron

Time frame
Birth to 36 weeks postmenstrual age (or prior to discharge if this occurs prior to 36 weeks)
4

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.

Time frame
at 7 days (prior to iron supplementation) and 4 weeks after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
Apply now