[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tracheo-esophageal-fistula-with-atresia-of-esophagus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tracheo-esophageal-fistula-with-atresia-of-esophagus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100495804","use-of-indocyanine-green-during-primary-repair-of-oesophageal-atresia-and-distal-tracheo-oesophageal-fistula-100495804",false,"NCT05735964","Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula","Indocyanine Green (ICG) and Near Infrared Fluorescence (NIRF) Guided Assessment of the Bowel and Oesophageal Anastomosis During Repair of Oesophageal Atresia with Distal Trachea-oesophageal Fistula (OA\u002FdTOF): a Cohort Pilot Study","iTOF","Inclusion Criteria:\n\nPre-operative\n\n* Diagnosis of oesophageal atresia with distal trachea-oesophageal fistula (OA\u002FdTOF)\n* Plan for primary or delayed primary oesophageal anastomosis\n\nIntra-operative\n\n* Diagnosis of OA\u002FdTOF confirmed by standard methods\n* Primary or delayed primary oesophageal anastomosis considered clinically, physiologically, and technically feasible\n\nExclusion Criteria:\n\nPre-operative\n\n* Under 2.5kg in weight\n* Complex cardiac disease\n* Allergic to ICG\n* Allergic to iodine or iodides\n* Hyperthyroidism\n* Chronic Kidney Disease stage V\n* Unwilling to participate\n* Those in whom exchange transfusion is indicated due to hyperbilirubinemia\n\nIntra-operative\n\n• Anaesthetic concerns contra-indicating the use of intravenous ICG due its temporary effect on oxygen saturation readings prior to injection of ICG","ALL","1 Year",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to look at babies having a primary or delayed primary oesophageal repair for OA with dTOF to evaluate if using Indocyanine green (ICG) and near infrared fluorescence (NIRF) can decrease the rates of anastomotic leaks and\u002For predict which patients they will happen in. The latter evaluation would help counsel parents and mean that further research can evaluate if other tactics can prevent the leak being a moderate or severe problem. These may include, but not be limited to, extra anastomotic sutures, insertion of a chest drain at the time of surgery (if this had not previously been considered) delaying oral feeding or using medications to dry up the saliva prophylactically (these medications have been shown to reduce the length of time it takes leaks to seal). Any technique that can reduce leak rates in oesophageal atresia is to be welcomed.\n\nAdditionally ICG may artifactually affect both peripheral oxygen readings (cause a transient decrease) and cerebral near infrared spectroscopy (NIRS) values (cause a transient increase). This is due to the temporary, dose dependent, interference of the dye with the mechanism of action of the monitoring rather than a physiological effect on oxygen levels. To date there has been no study investigating the effects of ICG on oxygen saturation and cerebral NIRS in neonates undergoing OA and\u002For dTOF repair.\n\nThe theory is an extension from adult practice following oesophagectomy for cancer where there was a reduction in anastomotic leaks when using ICG\u002FNIRF perfusion assessment. Another study in bariatric surgery using an enteral ICG\u002FNIRF assessment was highly sensitive for anastomotic leaks allowing management of them intra-operatively.\n\nObjectives are to\n\n1. Identify if the appearances of ICG\u002FNIRF can predict anastomotic leaks\n2. Identify if the ICG\u002FNIRF images would engender a change in operative management leading to a reduced leak rate\n3. Give a detailed report on the effects of ICG on oxygen readings This would be a cohort pilot study of 20 patients with the aim of informing a subsequent multi-centre Randomised controlled trial",[27],"Tracheo-Esophageal Fistula with Atresia of Esophagus","RECRUITING","2025-02-28",{"date":31,"type":32},"2025-03-04","ACTUAL",{"date":34,"type":32},"2023-03-01",{"date":36,"type":21},"2026-03",{"name":38,"class":39},"Birmingham Women's and Children's NHS Foundation Trust","OTHER"]