[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579888":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":18,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Georgetown University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise Group","EXPERIMENTAL","In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy.",[13],"Other: Post-frenotomy manual manipulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","In the control group, parents will not receive any instructions to perform \"suck re-training\" exercises or stretching following the procedure.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Post-frenotomy manual manipulation","Parents assigned to the treatment group will be instructed to perform post-frenotomy stretches and exercises four times daily, after every other feed, until the time of their postoperative visit 2-3 weeks later.",[9],[25],"Post-procedural exercises",[27],{"name":28,"affiliation":29,"role":30},"Earl H Harley, MD","MedStar Georgetown University Hospital","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Emily A Clementi, BA","CONTACT","(202) 444-8186","eac166@georgetown.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery","RECRUITING","Washington D.C.","District of Columbia","20007","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-77.03637,38.89511,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},{"type":30,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Earl H. Harley, Jr., MD","Chief of Pediatric Otolaryngology and Professor of Otolaryngology and Pediatrics","100579888","post-procedural-manual-manipulation-for-infant-ankyloglossia-100579888",false,"NCT06830148","Post-Procedural Manual Manipulation for Infant Ankyloglossia","Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial","Inclusion Criteria:\n\n* infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.\n\nExclusion Criteria:\n\n* infants older than 90 days, those who will be exclusively bottle fed, infants who undergo concomitant lip tie release, those who undergo laser frenotomy, and infants who have previously undergone a frenotomy.\n* infants with a gestational age of less than 36 weeks, those in the NICU or post-partum unit, infants who didn't receive the vitamin K injection, and those with congenital anomalies or medical conditions affecting breastfeeding","ALL","90 Days",{"count":67,"type":68},110,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance.\n\nInfants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). Parents in the intervention group will be instructed to perform tongue stretching and suck \"re-training\" exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. To monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. Parents in the control group will not be instructed to perform any post-procedural manipulation. All participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.",[74,75],"Ankyloglossia","Breastfeeding Support",[77,78,79,80,81,82],"tongue tie","breastfeeding","exercises","infant","pediatric otolaryngology","frenotomy","2025-02-11",{"date":85,"type":86},"2025-02-17","ACTUAL",{"date":88,"type":86},"2024-10-15",{"date":90,"type":68},"2025-11",{"name":5,"class":6},1]