[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574307":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":23,"responsibleParty":35,"collaborators":7,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":7,"studyType":50,"phases":7,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":62,"whyStopped":7,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"University Hospital of North Norway","OTHER",null,[9],{"name":10,"affiliation":5,"role":11},"Trond Flaegstad, MD, PhD","STUDY_DIRECTOR",[13,19],{"name":14,"role":15,"phone":16,"phoneExt":17,"email":18},"Claus Klingenberg, MD, PhD","CONTACT","91563167","+47","claus.klingenberg@unn.no",{"name":20,"role":15,"phone":21,"phoneExt":17,"email":22},"Nina Hapnes, MD","47448119","nina.clare.hapnes@sus.no",[24],{"facility":5,"status":7,"city":25,"state":7,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":7},"Tromsø","N-9038","Norway","NO",{"type":30,"coordinates":31},"Point",[32,33],18.95508,69.6489,{"lat":33,"lon":32},{"type":36,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100574307","necrotizing-enterocolitis-and-bowel-perforation-in-very-preterm-infants---long-term-follow-up-100574307",false,"NCT06757582","Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up","NOR-NEC","Inclusion Criteria:\n\n* Case: All Norwegian very preterm infants (gestational age (GA) \\\u003C 32 weeks) born during the 6-year period 2008-2013, diagnosed with surgical NEC or bowel perforation and surviving up to one year of age will be invited to participate as cases.\n* Controls: For each case we will invite two controls matched for important clinical characteristics (e.g. sex, GA, clinical illness score, intracranial pathology, need for oxygen at discharge etc.).\n\nExclusion Criteria:\n\n* not signing informed consent scheme","ALL","6 Years","15 Years",{"count":48,"type":49},150,"ESTIMATED","OBSERVATIONAL","Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and\u002For small bowel and subsequent intramural gas-forming organisms into the intestinal wall. Some preterm infants also develop spontaneous intestinal perforations (SIP) without the classical bowel inflammation\u002Fnecrosis seen in NEC. NEC and SIP can be challenging to differentiate. Severe cases of both conditions require surgery and often bowel resection, but mortality due to SIP seems lower.\n\nStudies looking at \"long-term prognosis\" of infants with NEC and bowel perforation have mainly assessed outcome until 2-7 years of age. The primary school years is a vulnerable period for ex-preterm children. Disruption in learning and social integration is of great importance for their quality of life (QoL), but little data exist in this age group. Moreover, nutritional deficits (e.g. cobalamin- or iron-deficiency may impact cognitive development, but this has not been investigated in this \"high-risk\" population in school age. Authors of a recent systematic review on gastrointestinal sequel after NEC-surgery thus called for \"more high-quality studies assessing long-term follow-up\".\n\nIn this project we will study the long-term impact of surgery for NEC and bowel perforation in preterm infants, both with a quality of life (QoL) perspective and with a focus on development, growth, nutrition and persistent gastrointestinal problems.",[53,54,55],"Necrotizing Enterocolitis","Intestinal Perforation","Premature Infant Disease",[57,58,59,60,61],"necrotizing enterocolitis","bowel perforation","preterm infant","long-term follow-up","quality of life","NOT_YET_RECRUITING","2025-01-02",{"date":65,"type":66},"2025-01-03","ACTUAL",{"date":68,"type":49},"2025-02-01",{"date":70,"type":49},"2027-08-01",{"name":5,"class":6},1]