[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601615":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":10,"responsibleParty":27,"collaborators":29,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":10},{"fullName":5,"class":6},"Great Ormond Street Hospital for Children NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"cardiac",null,"Infants aged from birth up to 3 months old, of any gestational age who require admission to a specialist cardiac centre for treatment of major congenital heart disease.",[13],{"name":14,"affiliation":5,"role":15},"Graeme O'Connor, PHD","PRINCIPAL_INVESTIGATOR",[17,23],{"name":18,"role":19,"phone":20,"phoneExt":21,"email":22},"Graeme O'Connor, PhD","CONTACT","+447958543828","5858","graeme.o'connor@gosh.nhs.uk",{"name":24,"role":19,"phone":25,"phoneExt":10,"email":26},"katherine Brown, MD PHD","+44204059200","Katherine.Brown@gosh.nhs.uk",{"type":28,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[30,32,34],{"name":31,"class":6},"University Hospital Southampton NHS Foundation Trust",{"name":33,"class":6},"Birmingham Children's Hospital",{"name":35,"class":6},"Alder Hey Children's NHS Foundation Trust","100601615","calprotectin-and-gut-disease-study-100601615",false,"NCT07112794","Calprotectin and Gut Disease Study","Single-test Accuracy Study to Assess the Diagnostic Value of Faecal Calprotectin to Diagnose Necrotising Enterocolitis in Infants With Heart Defects","SAFE NEC","Inclusion Criteria:\n\n* Infants aged from birth up to 3 months old, of any gestational age who require admission to a specialist cardiac centre for treatment of major congenital heart disease.\n\nIncluded patients are those who are judged as likely to require early cardiac surgery or interventional catheterisation, including babies who are treated with invasive medical therapies of respiratory support or intravenous vasoactive medications and their pathway will include a cardiac intervention of any type.\n\nExclusion Criteria:\n\n* Patients will be excluded if they are older than 3 months, do not have major heart disease and do have any gastrointestinal abnormality, including gastroschisis or imperforate anus.\n\nAlso, patients with neutropenia will be excluded since calprotectin is not activated when there is neutropenia.","ALL","0 Months","3 Months",{"count":48,"type":49},300,"ESTIMATED","OBSERVATIONAL","Necrotising enterocolitis (NEC) is a serious gut disease that can develop in infants born with cardiac defects. It causes inflammation and injury to the gut mucosa and may be life-threatening.1 The aetiology of NEC in cardiac infants is multifactorial, associated with poor cardiac outflow and poorly oxygenated systemic circulation, resulting in suboptimal blood flow to the intestines.2\n\nMaking an accurate and timely diagnosis of NEC is a significant clinical challenge.3 The clinical presentation of NEC is difficult to identify correctly in the early stages of the disease. Of concern, infants who are diagnosed with NEC at a later stage have worse disease.4 Due to the potentially life-threatening effects of NEC, clinicians who suspect a baby has NEC but are unable to confirm it, temporarily manage infants as if they have NEC as a precautionary measure.\n\nThis leads to infants without NEC having their milk feeds stopped for several days and being given unnecessary antibiotics. Compared to infants with confirmed NEC, the care of infants with suspected NEC is widely variable in terms of antibiotic regimen chosen, length of antibiotic treatment, and length of time nil-by-mouth - all these variabilities may adversely contribute to the length of hospital stay.5\n\nWe want to study a method to improve the accuracy of diagnosing NEC. We want to measure a protein marker found in babies' stools that, if combined with currently available tests (clinical features, lab tests and abdominal X-rays), 6,7 may improve the timeliness and accuracy of making a NEC diagnosis, crucially at an early stage of gut disease.\n\nThe protein marker is called calprotectin and monitoring levels in a baby's stools before and after heart surgery may help us to understand its relationship to NEC. Calprotectin is a biomarker that is released by white blood cells and is present in the gut when it is inflamed and can be measured in stool.8 The amount of calprotectin in the stool may indicate the level of gut inflammation and the presence of NEC in infants with heart defects.9\n\nThe addition of calprotectin measurement to the current routine parameters (clinical features, lab tests and abdominal X-rays) may improve the timeliness and accuracy of diagnosing NEC in infants with cardiac defects, hence improving their care pathway and outcomes.",[53],"Congenital Heart Disease",[55,56],"necrotising enterocolitis","Faecal Calprotectin","NOT_YET_RECRUITING","2025-08-01",{"date":60,"type":61},"2025-08-08","ACTUAL",{"date":63,"type":49},"2025-11-01",{"date":65,"type":49},"2027-12-01",{"name":5,"class":6}]