[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376599":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":7,"studyType":65,"phases":7,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":71,"whyStopped":7,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Great Ormond Street Hospital for Children NHS Foundation Trust","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DIAGNOSTIC_TEST","high resolution impedance manometry","Two detailed swallow assessments to be carried out at between 2-4 months and 8-10 months of age",[14],"videofluoroscopy swallow study",[16],{"name":17,"affiliation":18,"role":19},"Alex Stewart","Great Ormond Street Hospital for Children, London","PRINCIPAL_INVESTIGATOR",[21],{"name":22,"role":23,"phone":24,"phoneExt":7,"email":25},"Vanshree Patel, Dr","CONTACT","020 7905 42271","vanshree.patel@gosh.nhs.uk",[27],{"facility":28,"status":29,"city":30,"state":7,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Great Ormond Street Hospital for Children","RECRUITING","London","WC1N 3JH","United Kingdom","UK",{"type":35,"coordinates":36},"Point",[37,38],-0.12574,51.50853,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":7,"email":44},"Alexanra Stewart, MRes","020 7813 8110","alex.stewart@gosh.nhs.uk",{"type":46,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[48],{"name":49,"class":50},"National Institute for Health Research, United Kingdom","OTHER_GOV","100376599","swallowing-feeding-and-eating-in-children-born-with-oesophageal-atresiatrache-oesophageal-fistula-oatof-100376599",false,"NCT04183621","Swallowing, Feeding and Eating in Children Born With Oesophageal Atresia\u002FTrache-oesophageal Fistula (OA\u002FTOF)","A Mixed Methods Exploration of Early Feeding in Children Born With Oesophageal Atresia\u002FTrache-oesophageal Fistula.","SaFE","Inclusion Criteria:\n\n1. Diagnosis of OA and\u002For TOF\n2. Consent obtained from an adult with parental responsibility\n3. Under 5 months of age\n4. Undergone surgical repair\n5. Orally feeding at least 30mls at any one time\n6. Under the care of a Great Ormond Street Hospital Consultant\n\nExclusion Criteria:\n\n1. Unrepaired OA and\u002For TOF\n2. Repair requiring gastric transposition\u002Fjejunal transposition or other non-primary repair\n3. Fully tube fed\n4. Requiring non-invasive ventilation\n5. Under a child protection order","ALL","1 Month","4 Months",{"count":63,"type":64},20,"ESTIMATED","OBSERVATIONAL","How does oesophageal atresia\u002Ftrache-oesophageal fistula affect feeding and swallowing in the first year of life?\n\nApproximately 150 babies a year are born with oesophageal atresia and\u002For trache-oesophageal atresia. Oesophageal atresia occurs when the oesophagus (food pipe) fails to join up during early foetal development. Trache-oesophageal fistula describes an abnormal connection that forms between the oesophagus and trachea (wind pipe). When the baby feeds, milk cannot pass into the stomach but can pass into the lungs.\n\nSurgery is needed within the first few days of life and is extremely successful, with 90-95% of babies surviving. However, approximately 50-80% of babies will have ongoing feeding or swallowing difficulties resulting in choking, chest infections and pneumonia. They can also lead to food refusal, distress at mealtimes and parental anxiety.\n\nCurrently there is limited understanding of:\n\n* the exact nature of the feeding and swallowing difficulties\n* the risk factors for developing difficulties\n* the impact on parents.\n\nThis study will address these issues through two complimentary projects:\n\nProject 1: A study of swallow physiology Babies with oesophageal atresia and\u002For trache-oesophageal fistula who have surgery at Great Ormond Street Hospital will be invited to have a detailed swallow assessment using videofluoroscopy (video x-ray) and high resolution impedance manometry (a pressure monitor) at 2-4 months of age and at 8-12 months of age. Results will be compared to parent report of feeding at 1 year old.\n\nProject 2: A study of the impact on parental well-being This study will be carried out in conjunction with the 'TOFS' support group. A Facebook page will be used to carry out an online forum. Parents of any child who has had TOF\u002FOA will be invited to share their experiences of establishing feeding. This information will be used to develop a questionnaire to look at how wide-ranging these experiences are.",[68],"Esophageal Atresia With Tracheoesophageal Fistula",[70],"deglutition","UNKNOWN","2022-03-18",{"date":74,"type":75},"2022-03-21","ACTUAL",{"date":77,"type":75},"2020-12-15",{"date":79,"type":64},"2024-04",{"name":5,"class":6},1]