[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455687":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":39,"locations":48,"responsibleParty":520,"collaborators":523,"id":532,"slug":533,"hasResults":534,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":534,"sex":540,"minAge":23,"maxAge":541,"enrollmentInfo":542,"targetDuration":23,"studyType":545,"phases":546,"briefSummary":548,"conditions":549,"keywords":551,"overallStatus":51,"whyStopped":23,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":565},{"fullName":5,"class":6},"IWK Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Withholding feeds around transfusion","ACTIVE_COMPARATOR","All enteral feeds will be discontinued (the infant will be placed nil by mouth) for 4 hours prior to packed red cell transfusion, during the transfusion and until 4 hours post transfusion. During this period, hydration and blood glucose will be maintained according to local practice, commonly by providing parenteral nutrition or intravenous dextrose. Four hours after the red cell transfusion has finished, feeds will be recommenced to how they were being received prior to the decision to transfuse. This duration of withholding feeds will follow the approach used in other trials and observational studies, and identified as the most acceptable in a survey of UK neonatal units. It gives time for milk in the small bowel to transit into the large bowel before the transfusion and for the circulation to stabilize after the transfusion before milk feeds given into the stomach pass through into the small intestine.",[13],"Other: Withholding feeds around transfusion",{"label":15,"type":10,"description":16,"interventionNames":17},"Continuing feeds around transfusion","Enteral feeds will continue to be given prior, during and after the packed red cell transfusion, in the manner in which they were being given prior to the decision to transfuse. Infants will remain allocated to the same care pathway until 34(+6) weeks(+days) gestational age.",[18],"Other: Continued feeds around transfusion",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"Withholding enteral feeds for preterm infants (\\\u003C30 weeks) around the time of blood transfusions to determine if any impact on the development and\u002For severity of Necrotizing Enterocolitis.",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Continued feeds around transfusion","Continued enteral feeds",[15],[29,33,36],{"name":30,"affiliation":31,"role":32},"Balpreet Singh, MD","IWK Health, Canada","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Jon Dorling, MD","Princess Anne Hospital, UK",{"name":37,"affiliation":38,"role":32},"Chris Gale, MD","Imperial College London, UK",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Cari-Lee 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Preterm birth at \\\u003C30+0 gestational weeks + days\n\nExclusion Criteria:\n\n1. Parent(s) opt-out of trial participation.\n2. Packed red cell transfusion with concurrent enteral feeds prior to enrolment. (Infants who have received a packed red cell transfusion while nil-by-mouth are eligible; or minimal enteral nutrition (\\\u003C15 ml\u002Fkg\u002Fday feeds) at the time of transfusion; defined as before, during and for at least 4 hours after transfusion, are eligible.\n3. Infants who are not being fed at the time of randomization (\\\u003C15ml\u002Fkg) or where enteral feeding is contraindicated \\[e.g. Major congenital abnormality of the gastrointestinal tract (GIT)\\].\n4. Previous episode of NEC Bell stage 2 or higher or SIP prior to first study packed cell transfusion.","ALL","30 Weeks",{"count":543,"type":544},4333,"ESTIMATED","INTERVENTIONAL",[547],"NA","The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (\\\u003C30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Currently both continued feeding and withholding feeding are approved care practices. The current study will randomize infants from Neonatal Intensive Care Units (NICUs) across Canada and the United Kingdom (UK) into one of the two care approaches (withholding or continued feeds) to determine if any significant outcomes are found.",[550],"Necrotizing Enterocolitis",[552,550,553,554,555],"Comparative Effectiveness Trial","Premature Infants","Blood Transfusion","Withholding enteral feeds","2026-04-21",{"date":558,"type":559},"2026-04-24","ACTUAL",{"date":561,"type":559},"2022-01-28",{"date":563,"type":544},"2027-03-31",{"name":5,"class":6},40]