[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595704":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":18,"responsibleParty":39,"collaborators":18,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":18,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":18,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":67,"whyStopped":18,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":18},{"fullName":5,"class":6},"Nationwide Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group: PIONEER Protocol","EXPERIMENTAL","PIONEER© Protocol\n\n* Oral nutritive stimulus with every feed (minimum 5mL)\n* Esophageal stimulation with up to 15 stimulations given at least 5 times per week with stimulation catheter\n* High resolution esophageal manometry as much as weekly if feasible throughout protocol\n* Parent biofeedback (during manometry studies) and education on at least a weekly basis with focus on their participation in oral feeding",[13],"Combination Product: PIONEER Protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group: Standard of care treatment","NO_INTERVENTION","Standard of care feeding:\n\nCue based po feeds done per the unit protocol",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"COMBINATION_PRODUCT","PIONEER Protocol","* Oral nutritive stimulus with every feed (minimum 5mL)\n* Esophageal stimulation with up to 15 stimulations given at least 5 times per week with stimulation catheter\n* High resolution esophageal manometry as much as weekly if feasible throughout protocol\n* Parent biofeedback (during manometry studies) and education on at least a weekly basis with focus on their participation in oral feeding",[9],[26],{"name":27,"affiliation":5,"role":28},"Sudarshan Jadcherla","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Erika K Osborn","CONTACT","6143556667","erika.osborn@nationwidechildrens.org",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Patty Luzader","6143556697","patty.luzader@nationwidechildrens.org",{"type":28,"investigatorFullName":27,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Physician - Neonatology Central Campus","100595704","novel-pioneer-protocol-rct-100595704",false,"NCT07035912","Novel PIONEER© Protocol: RCT","Randomized Controlled Trial Evaluating the Impact of a Novel Parent Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Program on Hospitalized Infants With Feeding Challenges","INCLUSION CRITERIA:\n\n1. Nasogastric tube fed infants referred for diagnostic manometry and Gastrostomy tube planning evaluations.\n2. Physiologically stable convalescing infants on full enteral feeds at greater than or equal to 37.0 weeks and less than 46 weeks postmenstrual age.\n3. Presence of aerodigestive reflexes on diagnostic manometry.\n\nEXCLUSION CRITERIA\n\n1. Potentially lethal congenital or chromosomal anomalies\n2. Craniofacial defects (cleft lip or palate)\n3. History of GI surgery, ENT surgery, or neurosurgery\n4. Need for supplemental respiratory support of \\>2 LPM","ALL","1 Week","6 Months",{"count":52,"type":53},134,"ESTIMATED","INTERVENTIONAL",[56],"NA","Neonatal ICU survivors often face challenges with oral eating, swallowing difficulties, and various aerodigestive issues, and commonly need chronic nasogastric tube feeding or gastrostomy feeding, which escalates socioeconomic burdens, hospital stays, neurodevelopmental delays, and parental suffering. This proposal addresses a vital need in neonatal gastroenterology by studying unique swallowing mechanisms and defining the basis for preventative and corrective therapies through new translational research initiatives via a randomized controlled trial using the novel intervention initiative- Parent Implemented Oral Nutrition, Eating, and Esophageal reflexes Reintegration (PIONEER©) protocol.",[59,60],"Deglutition Disorders in Infants","Chronic Tube Feeding in Hospitalized Infants",[62,63,64,65,66],"Neonatal","Deglutition Disorders","NICU infants","Gastrostomy prevention","Chronic tube feeding","NOT_YET_RECRUITING","2026-01-14",{"date":70,"type":71},"2026-01-16","ACTUAL",{"date":73,"type":53},"2026-07-01",{"date":75,"type":53},"2032-06-30",{"name":5,"class":6}]