[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Birmingham Women's and Children's NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100053278","the-dirty-nappy-study-100053278",false,"NCT07697872","The Dirty Nappy Study","The Dirty Nappy Study: Development and Evaluation of a Machine Learning Algorithm for the Early Detection of Cholestasis and Biliary Atresia From Parent-Provided Images of Dirty Nappies","Inclusion Criteria:\n\nAll Arms:\n\nInformed Consent: Parents\u002Fguardians can give informed consent for their child's participation in the study and can understand written English.\n\n1. Retrospective Cholestasis Arm:\n\n   All infants, of any gestation, male and female who were referred to Birmingham Liver Unit from any hospital for investigation of suspected cholestasis within the previous 10 years before the study launch. At the time of the referral to Birmingham Liver Unit the children were under the age of 6 months and the children were referred before the start date of the study.\n2. Prospective Cholestasis Arm:\n\n   All infants, of any gestation, male and female who were referred to Birmingham Liver Unit from any hospital for investigation of suspected cholestasis after the study launch. At the time of the referral to Birmingham Liver Unit the children were under the age of 6 months.\n3. Prospective Non-Cholestasis Arm All infants, of any gestation, male and female \\& aged less than 28 days, not thought to be cholestatic at the time of recruitment \\& with the birth registered at any of the participating hospital trusts.\n\nExclusion Criteria:\n\nIf the inclusion criteria as outlined are met, there is no exclusion criteria.",true,"ALL","11 Years",{"count":20,"type":21},5350,"ESTIMATED","OBSERVATIONAL","This observational study evaluates whether a machine-learning algorithm, a computer program that learns patterns from data, can accurately diagnose cholestasis in newborns. Cholestasis refers to reduced or blocked bile flow from the liver, which can lead to liver damage. A severe form of cholestasis is biliary atresia, a condition where the bile ducts are damaged or absent, requiring early treatment to prevent long-term harm.\n\nThe study involves infants from birth, both healthy and those potentially affected by cholestasis, recruited from four UK hospitals. It addresses two primary aims:\n\n* Accuracy of Diagnosis: Can the machine-learning algorithm accurately identify cholestasis and biliary atresia using parent-provided stool images? This will be assessed by measuring sensitivity (the ability to correctly detect true cases) and specificity (the ability to correctly identify infants without the condition).\n* Feasibility of Screening: Is using parent-provided images a feasible and acceptable screening method for early detection?\n\nTo evaluate these aims, researchers will compare two groups:\n\n* Infants with abnormal stool images who are subsequently diagnosed with cholestasis or biliary atresia.\n* Infants with normal stool images who do not develop biliary atresia.\n\nThis comparison will help determine the algorithm's ability to distinguish between infants with and without these conditions.\n\nParents will:\n\n* Take smartphone photos of their baby's dirty diapers at 14, 21, and 28 days of age.\n* Upload the images for analysis by the algorithm.\n* Provide feedback on their experience with this screening process.\n\nThe study seeks to determine if parent-submitted stool images can serve as a practical early screening tool for cholestasis, potentially enabling faster diagnosis and improved outcomes for affected infants.",[25,26,27],"Cholestasis in Newborn","Biliary Atresia","Neonatal Cholestasis",[29,30,31,32,33,34,35,36],"Neonatal cholestasis","Biliary atresia diagnosis","Newborn stool analysis","infant liver disease","screening","machine learning","AI","image analysis","RECRUITING","2026-07-06",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2025-04-01",{"date":45,"type":21},"2026-09-30",{"name":47,"class":48},"Birmingham Women's and Children's NHS Foundation Trust","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":49},"100495804","use-of-indocyanine-green-during-primary-repair-of-oesophageal-atresia-and-distal-tracheo-oesophageal-fistula-100495804","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","1 Year",{"count":60,"type":21},20,"INTERVENTIONAL",[63],"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",[66],"Tracheo-Esophageal Fistula with Atresia of Esophagus","2025-02-28",{"date":69,"type":41},"2025-03-04",{"date":71,"type":41},"2023-03-01",{"date":73,"type":21},"2026-03",{"name":47,"class":48},""]