[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452371":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":12,"locations":25,"responsibleParty":50,"collaborators":54,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":12,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":12,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":12,"overallStatus":28,"whyStopped":12,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of South Carolina","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard care","NO_INTERVENTION","Standard care\u002FControl group: The nurse will receive the PRBC transfusion from the Blood\n\nBank. As standard care, there are no deliberate procedures for warming PRBC transfusions in this NICU. The syringe of blood may sit outside the incubator for some time and as such, will warm to the environmental ambient temperature while transfusing into the infant using a standard pump. The transfusion will be given over 4 hours, per the clinician's orders. The bedside nurse will document transfusion start and stop times, and route, on the study document at the bedside. The infant will end study participation 24 hours after the PRBC transfusion is complete to verify that all temperature data have been received and are valid.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention","ACTIVE_COMPARATOR","Intervention group: Once a nurse receives the PRBC from the Blood Bank, the nurse will\n\nobtain a specialized tubing and use a commercial PRBC warming device, the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) to deliver the PRBC transfusion to the infant. The unit contains highly responsive aluminum heating plates that distribute heat quickly, which\n\nresponds to flow changes with even and consistent heat. The plate temperature is monitored 4 times per second and is accurate within 1°C (3M Healthcare, Oakdale, Minnesota). The Ranger blood warmer meets the American Association of Blood Bank (AABB) guidelines for warming blood. All times and information associated with the PRBC transfusion will be recorded on the bedside study document. The transfusion will be given over 4 hours, per the clinician's orders. The infant will end study participation 24 hours after the PRBC transfusion is complete to verify that all temperature data have been received and are valid.",[18],"Device: Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)","70 random infant will receive the packed red blood cell transfusion with the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)",[14],[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Kayla Everhart","RECRUITING","Columbia","South Carolina","29208","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-81.03481,34.00071,{"lat":38,"lon":37},[41,46],{"name":42,"role":43,"phone":44,"phoneExt":12,"email":45},"Kayla Everhart, PhD","CONTACT","910-471-5958","everhakc@email.sc.edu",{"name":47,"role":43,"phone":48,"phoneExt":12,"email":49},"Victor N Iskersky, MD","803-434-2912","Victor_Iskersky@MEDNAX.com",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Kayla Chavis Everhart, PhD, RN","Assistant Professor",[55,57],{"name":56,"class":6},"The Gerber Foundation",{"name":58,"class":6},"Prisma Health-Midlands","100452371","blood-warming-in-preterm-infants-to-decrease-hypothermia-100452371",false,"NCT05170633","Blood Warming in Preterm Infants to Decrease Hypothermia","Evaluation of a Blood Warming Device for Packed Red Blood Cell Transfusions to Decrease Hypothermia in Very Preterm Infants","Inclusion Criteria:\n\n* Any infant born at PRISMA Health Richland hospital\n* less than 32 weeks gestational age by obstetrical dating as indicated in the electronic medical chart\n* admitted to the neonatal intensive care unit receiving one PRBC transfusion within the first month of life.\n\nExclusion Criteria:\n\n* Infants having neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV), because neurological damage can interfere with thermal control.",true,"ALL","24 Weeks","32 Weeks",{"count":71,"type":72},140,"ESTIMATED","INTERVENTIONAL",[75],"NA","Background\u002Fsignificance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia. Hypothermia has been defined as a contributor of neonatal morbidity by The World Health Organization. Another acute morbidity is anemia in preterm infants due to the prematurity and frequent laboratory testing. Anemia requires correction with a packed red blood cells (PRBC) transfusion.\n\nResearchers have previous noted hypothermia during PRBC transfusions in preterm infants. Objective: To use a commercial blood warmer in the neonatal intensive care setting to prevent hypothermic body temperatures (\\\u003C36.5°C) in very preterm infants during PRBC transfusions.\n\nProcess: Based on a completed national survey of neonatal intensive care nurses and PRBC transfusion practices and personal NICU experience, we designed this randomized control trial in 140 very preterm infants in a Southeastern, level III neonatal intensive care unit.\n\nOutcomes: Very preterm infants (\\\u003C32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a lower incidence of central body hypothermia post transfusion (temperatures \\\u003C36.5C), compared to infants receiving PRBC transfusions by standard of care. Very preterm infants (\\\u003C32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a higher post transfusion mean abdominal skin body temperature when compared to infants receiving PRBC transfusions by standard of care.\n\nHypothesis : The results of this trial could show that very preterm infants experience hypothermia during PRBC transfusions, and thus provide the evidence to support the need for warmed PRBC transfusions in very preterm infants nationwide.",[78,79,80],"Preterm Birth","Blood Transfusion Complication","Hypothermia","2024-12-05",{"date":83,"type":84},"2024-12-11","ACTUAL",{"date":86,"type":84},"2022-01-01",{"date":88,"type":72},"2026-01-01",{"name":5,"class":6},1]