[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465418":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":63,"centralContacts":67,"locations":77,"responsibleParty":105,"collaborators":108,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":71,"maxAge":121,"enrollmentInfo":122,"targetDuration":71,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":134,"overallStatus":79,"whyStopped":71,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of Washington","OTHER",[8,14,21,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1. Oral iron","ACTIVE_COMPARATOR","Oral iron is started on day 7 of life if baby is feeding 100 mL\u002Fkg\u002Fday. Iron supplements of up to 12 mg\u002Fkg\u002Fday are given based on CBC, retic, ret-hgb, serum ferritin and zinc protoporphyrin to heme ratio (ZnPP\u002FH). Iron supplements are adjusted every 2 weeks following iron studies.",[13],"Drug: Oral iron supplements",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2","EXPERIMENTAL","Infants randomized to this arm will receive Darbe 10 mcg\u002Fkg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 10 mg\u002Fkg x 1, retreat if ferritin \\\u003C 76 mcg\u002FL",[19,20],"Drug: Darbepoetin Alfa","Drug: Low Molecular Weight Iron Dextran",{"label":22,"type":16,"description":23,"interventionNames":24},"Group 3","Infants randomized to this arm will receive Darbe 10 mcg\u002Fkg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 20 mg\u002Fkg x 1, retreat if ferritin \\\u003C 76 mcg\u002FL",[19,20],{"label":26,"type":16,"description":27,"interventionNames":28},"Group 4","Infants randomized to this arm will receive Darbe 10 mcg\u002Fkg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 10 mg\u002Fkg x 1, retreat if ferritin \\\u003C 76 mcg\u002FL",[19,29],"Drug: Ferumoxytol injection",{"label":31,"type":16,"description":32,"interventionNames":33},"Group 5","Infants randomized to this arm will receive Darbe 10 mcg\u002Fkg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 20 mg\u002Fkg x 1, retreat if ferritin \\\u003C 76 mcg\u002FL",[19,29],[35,43,50,57],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Darbepoetin Alfa","Infants in groups 2-5 will be started on Darbe 10 mcg\u002Fkg\u002Fweek between 72 and 84 hours after birth.",[15,22,26,31],[41,42],"Aranesp","Darbe",{"type":36,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Low Molecular Weight Iron Dextran","Infants in groups 2 and 3 will be given LMW-ID IV, 10 or 20 mg\u002Fkg\u002Fdose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly.",[15,22],[48,49],"INFeD","LMW-ID",{"type":36,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Ferumoxytol injection","Infants in groups 4 and 5 will be given FMX IV, 10 or 20 mg\u002Fkg\u002Fdose. They will be re-dosed if ferritin falls below 76. Iron parameters will be checked biweekly.",[26,31],[55,56],"Feraheme","FMX",{"type":36,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Oral iron supplements","Infants in group 1 will receive standard care in the UW NICU with iron started on day 7 if tolerating 100 mL\u002Fkg\u002Fday enteral feeding. Iron supplements are adjusted every 2 weeks based on ferritin, zinc protoporphyrin to heme ratio and complete blood count (CBC).",[9],[62],"Ferr-in-sol",[64],{"name":65,"affiliation":5,"role":66},"Kendell R German, MD","PRINCIPAL_INVESTIGATOR",[68,73],{"name":65,"role":69,"phone":70,"phoneExt":71,"email":72},"CONTACT","(206)221-5716",null,"germank@uw.edu",{"name":74,"role":69,"phone":75,"phoneExt":71,"email":76},"John Feltner, MS","206 616-8021","jfeltner@uw.edu",[78],{"facility":5,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"RECRUITING","Seattle","Washington","98195","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-122.33207,47.60621,{"lat":89,"lon":88},[92,93,96,97,99,101,103],{"name":74,"role":69,"phone":75,"phoneExt":71,"email":76},{"name":94,"role":95,"phone":71,"phoneExt":71,"email":71},"Sandra E Juul, MD, PhD","SUB_INVESTIGATOR",{"name":65,"role":66,"phone":71,"phoneExt":71,"email":71},{"name":98,"role":95,"phone":71,"phoneExt":71,"email":71},"Dennis E Mayock, MD",{"name":100,"role":95,"phone":71,"phoneExt":71,"email":71},"Sarah Kolnik, MD",{"name":102,"role":95,"phone":71,"phoneExt":71,"email":71},"Sara Neches, MD",{"name":104,"role":95,"phone":71,"phoneExt":71,"email":71},"Katie Strobel, MD",{"type":66,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":71,"oldOrganization":71},"Kendell German","Associate Professor: School of Medicine, Pediatrics",[109],{"name":110,"class":111},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100465418","phase-2-darbe-plus-iv-iron-to-decrease-transfusions-while-maintaining-iron-sufficiency-in-preterm-infants-100465418",false,"NCT05340465","Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants","Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants","DIVI","Inclusion Criteria:\n\n• NICU patients (male and female) born at 24-0\u002F7 to 31-6\u002F7 weeks of gestation\n\nAll patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.\n\nExclusion Criteria:\n\n* Known fetal\u002Finfant anomalies of clinical significance (brain, cardiac, chromosomal anomalies)\n* Parental consent unable to be obtained by 72 hours after birth\n* Central hematocrit \\> 65%\n* Evidence of high iron stores prior to enrollment (e.g. Ferritin \\>400 ng\u002FmL with corresponding ZnPP\u002FH of \\\u003C30, Transferrin saturation \\>75%, iron \\> 200 mcg\u002FdL, TIBC \\\u003C 100 mcg\u002FdL)\n* Culture proven sepsis, meningitis, urinary tract infection, or other significant infection at the time of enrollment\n* Mother under 18 years of age\n* Unable to consent in English or Spanish","ALL","3 Days",{"count":123,"type":124},120,"ESTIMATED","INTERVENTIONAL",[127],"PHASE2","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.\n\nInvestigators hypothesize that in infants \\\u003C 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",[130,131,132,133],"Prematurity","Iron-deficiency","Iron Deficiency Anemia","Iron Malabsorption",[135,136,137,138,139],"prematurity","iron deficiency","anemia","darbepoetin","IV Iron","2026-05-21",{"date":142,"type":143},"2026-05-26","ACTUAL",{"date":145,"type":143},"2022-11-27",{"date":147,"type":124},"2027-06-30",{"name":5,"class":6},1]