[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525204":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":48,"collaborators":20,"id":51,"slug":20,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Nationwide Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants with Complex Feeding Difficulties","EXPERIMENTAL","Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy",[13],"Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy","Subjects will be given weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry for 4 weeks. During this time of study intervention, every feed will start with nutritive oral stimulation with at least 5 mL of the infant's prescribed diet.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Sudarshan Jadcherla","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Erika K Osborn","CONTACT","6143556667","erika.osborn@nationwidechildrens.org",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Patty Luzader","6143556627","patty.luzader@nationwidechildrens.org",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":20},"RECRUITING","Columbus","Ohio","43205","United States",{"type":43,"coordinates":44},"Point",[45,46],-82.99879,39.96118,{"lat":46,"lon":45},{"type":49,"investigatorFullName":23,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Principal Investigator, Innovative Feeding Disorders Research Program","100525204",false,"NCT06118697","Feasibility of Aerodigestive Stimulation Therapy Trial","Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties","FAST","Inclusion Criteria:\n\n* NICU infant ≥37 weeks postmenstrual age not taking full oral feeds\n* Consult to Neonatal \\& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered\n* Presence of peristaltic and sphincteric reflexes at initial manometry\n\nExclusion Criteria:\n\n* Potentially lethal chromosomal anomalies\n* Craniofacial malformations\n* Foregut malformations","ALL","1 Day","8 Months",{"count":62,"type":63},40,"ESTIMATED","INTERVENTIONAL",[66],"NA","The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are:\n\n* To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding.\n* To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding.\n\nParticipants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.",[69],"Feeding Disorder Neonatal",[71,72,73,74],"Chronic tube feeding","Gastrostomy","Deglutition","Esophageal manometry","2026-04-29",{"date":77,"type":78},"2026-05-05","ACTUAL",{"date":80,"type":78},"2024-02-05",{"date":82,"type":63},"2028-11-01",{"name":23,"class":6},1]