[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474242":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Patients will be undergo 1 week observation period followed by 4 weeks of prucalopride followed by 1 weeks of a wash out followed by 4 weeks of famotidine",[13,14],"Drug: Prucalopride","Drug: Famotidine",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2","Patients will be undergo 1 week observation period followed by 4 weeks of famotidine followed by 1 weeks of a wash out followed by 4 weeks of prucalopride",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Prucalopride","Prucalopride 0.04 mg\u002Fkg\u002Fday",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Famotidine","Famotidine 0.4 mg\u002Fkg\u002Fday",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Rachel Rosen, MD","CONTACT","617-355-0897","rachel.rosen@childrens.harvard.edu",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-71.05977,42.35843,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":35},"Rachel Rosen Principal Investigator","6173556055",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Rachel Rosen","Associate Professor of Pediatrics","100474242","phase-4-gastrointestinal-dysmotility-on-aspiration-risk-100474242",false,"NCT05455359","Gastrointestinal Dysmotility on Aspiration Risk","The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms","Inclusion Criteria:\n\n1. are 5-21 years of age;\n2. receive \\>90% of their calories by enteral tube (i.e., patients take no food or drink by mouth);\n3. are determined to be at high risk for aspiration pneumonia based on evidence of impaired airway protective mechanisms, documented by aspiration on video fluoroscopic swallow study;\n4. have static neurologic impairment, defined as functional and\u002For intellectual impairment that results from a chronic neurologic or related diagnosis (e.g., cerebral palsy) with no prospect of progression for at least one year;\n5. have chronic respiratory symptoms, defined as coughing, choking, or need for oral suctioning a minimum of three times per week during the prior four weeks.\n\n   \\-\n\nExclusion Criteria:\n\n1. have progressive neurologic impairment;\n2. have a history of prior intact Nissen fundoplication;\n3. are currently taking oral or inhaled antibiotics, including prophylactic antibiotics;\n4. are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or\n5. are fed by gastrojejunostomy rather than by gastrostomy. -","ALL","5 Years","21 Years",{"count":69,"type":70},120,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.",[76,77,78,79],"Esophageal Motility Disorders","Gastric Motor Dysfunction","Aspiration Pneumonia","Gastro Esophageal Reflux","2025-12-23",{"date":82,"type":83},"2025-12-26","ACTUAL",{"date":85,"type":83},"2025-02-13",{"date":87,"type":70},"2027-05-31",{"name":5,"class":6},1]