[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462841":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":12,"centralContacts":29,"locations":38,"responsibleParty":72,"collaborators":12,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":12,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Liverpool","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard parenteral nutrition","NO_INTERVENTION","These infants will form the control group and will receive standard parenteral nutrition. They will be sub-stratified into gestational brackets - preterm (born \\\u003C30 weeks) and term\u002Fnear term.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Arginine supplementation (combined)","EXPERIMENTAL","These infants will form an intervention group and will receive parenteral nutrition with additional arginine (up to 18% of amino acid make-up) for up to 14 days post-op and oral arginine supplementation up to 30 days post-op. They will be sub-stratified into gestational brackets - preterm (born \\\u003C30 weeks) and term\u002Fnear term.",[18],"Dietary Supplement: Arginine",{"label":20,"type":15,"description":21,"interventionNames":22},"Arginine supplementation (oral only)","These infants will form an intervention group and will receive standard parenteral nutrition and oral arginine supplementation up to 30 days post-op. They will be sub-stratified into gestational brackets - preterm (born \\\u003C30 weeks) and term\u002Fnear term.",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DIETARY_SUPPLEMENT","Arginine","The intervention infants will receive either parenteral nutrition which contains additional arginine (up to 18% arginine content) or a separate arginine infusion to provide up to 18% arginine. This is in comparison to standard parenteral nutrition which has an arginine content of 6.3%.",[14,20],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Colin Morgan","CONTACT","+441517089988","colin.morgan@lwh.nhs.uk",{"name":36,"role":32,"phone":33,"phoneExt":12,"email":37},"Frances Callaghan","frances.callaghan@nhs.net",[39,60],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Alder Hey Children's Hospital","RECRUITING","Liverpool","Merseyside","L14 5AB","United Kingdom","UK",{"type":48,"coordinates":49},"Point",[50,51],-2.97794,53.41058,{"lat":51,"lon":50},[54,57],{"name":55,"role":32,"phone":56,"phoneExt":12,"email":12},"Emma Rutherford","01512284811",{"name":58,"role":59,"phone":12,"phoneExt":12,"email":12},"Daniel Hawcutt","PRINCIPAL_INVESTIGATOR",{"facility":61,"status":41,"city":42,"state":43,"zip":62,"country":45,"countryCode":46,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Liverpool Women's Hospital","L8 7SS",{"type":48,"coordinates":64},[50,51],{"lat":51,"lon":50},[67,70],{"name":68,"role":32,"phone":69,"phoneExt":12,"email":12},"Louise Hardman","01517024346",{"name":71,"role":59,"phone":12,"phoneExt":12,"email":12},"Frances Callaghan, MBChB",{"type":73,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100462841","an-exploratory-study-of-arginine-supplementation-and-the-postoperative-immune-response-100462841",false,"NCT05306925","An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse","An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse (ASPIRE)","ASPIRE","Inclusion Criteria:\n\n* Preterm infants born \\\u003C30 weeks gestation requiring laparotomy\u002Fmajor bowel surgery or diagnosed with necrotising enterocolitis (Modified Bell's Stage II or higher) before discharge\n* Term and near term infants (born\\>35 weeks gestation) requiring laparotomy\u002Fmajor bowel surgery in the first 3 days of life (gastroschisis; major bowel atresias expected to require at least 7 days of PN)\n\nExclusion Criteria:\n\n* Infants who are unlikely to survive because of poor immediate postoperative condition\n* Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction\n* Parents who are unable to give informed consent","ALL","22 Weeks","44 Weeks",{"count":86,"type":87},48,"ESTIMATED","INTERVENTIONAL",[90],"NA","ASPIRE is a nutrition study focusing on the effect of arginine supplementation on immune function in postoperative infants.\n\nThe investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations and oral arginine supplementation on blood arginine levels and the genes that are involved in body nutrition and fighting infection in babies who have had major bowel surgery or been diagnosed with necrotising enterocolitis. The investigators will undertake an exploratory physiological study across two sites under which are part of a single neonatal partnership. 48 infants will be recruited; 24 preterm infants and 24 term\u002Fnear term infants. 16 of these infants (8 preterm and 8 term\u002Fnear term) will be supplemented with arginine in both oral and parenteral form, 16 infants will receive arginine supplementation in oral form alone and 16 infants will receive standard nutrition with no arginine supplement. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days post surgery or post NEC diagnosis. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and metabolomics. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in postoperative infants\n\nThe investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.",[93,94,95,96],"Preterm","Surgery","Nutritional Deficiency","Immune System and Related Disorders",[98,26,99,100,101],"Neonate","Postoperative","Immune function","Nutrition","2026-02-17",{"date":104,"type":105},"2026-02-18","ACTUAL",{"date":107,"type":105},"2022-04-14",{"date":109,"type":87},"2026-12-31",{"name":5,"class":6},2]