[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cleft-lip\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cleft-lip":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,82,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100642485","perioperative-respiratory-adverse-events-in-cleft-lip-and-palate-surgery-incidence-risk-factors-and-clinical-scoring-100642485",false,"NCT07651904","Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring","Prospective Assessment of Perioperative Respiratory Adverse Events in Pediatric Patients Undergoing Cleft Lip and Palate Surgery: Predictive Risk Factors and the Role of Clinical Airway Scores","Inclusion Criteria:\n\n* Age 0-3 years (infants and toddlers)\n* Scheduled for elective cleft lip and\u002For palate repair surgery\n* General anesthesia planned\n* Written parental\u002Fguardian informed consent obtained\n\nExclusion Criteria:\n\n* Pre-existing respiratory failure or active tracheostomy\n* Emergency surgical procedures\n* Inability to obtain parental\u002Fguardian consent","ALL","0 Years","3 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","Cleft lip and palate surgeries present unique anesthetic challenges due to shared airway access with the surgical field, frequent anatomical abnormalities, and a predominantly infant and toddler population. These factors substantially increase the risk of perioperative respiratory adverse events (PRAEs), including laryngospasm, bronchospasm, desaturation, post-extubation stridor, and unanticipated re-intubation.\n\nThis prospective single-center observational cohort study aims to determine the true incidence of PRAEs in pediatric patients undergoing elective cleft lip and\u002For palate repair under general anesthesia, and to identify independent predictive risk factors using standardized airway assessment tools including the Han Mask Ventilation Score and the Intubation Difficulty Score (IDS). No interventions beyond routine clinical practice will be applied. All airway management decisions will remain at the discretion of the attending anesthesiologist.",[25,26,27,28,29,30,31],"Cleft Palate","Cleft Lip","Laryngospasm","Bronchospasm","Airway Obstruction","Postoperative Complications","Difficult Intubation",[33,34,35,36,37,38,39],"cleft lip","cleft palate","pediatric anesthesia","perioperative respiratory adverse events","Han mask ventilation score","micrognathia","intubation difficulty score","NOT_YET_RECRUITING","2026-06-13",{"date":43,"type":44},"2026-06-16","ACTUAL",{"date":46,"type":21},"2026-06-27",{"date":48,"type":21},"2027-12-30",{"name":50,"class":51},"Marmara University Pendik Training and Research Hospital","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100466696","effects-of-alignbabycleft-abacleft-100466696","NCT05357092","Effects of AlignBabyCleft (ABaCleft)","Evaluation of Presurgical Orthopedics in Patients With Cleft Lip and\u002For Palate, a Randomized Controlled Clinial Trial.","(ABaCleft)","Inclusion Criteria:\n\nPatients selected for the clinical trial must meet these criteria after randomization:\n\n* All patients born at term, without any syndrome associated with CLP, aged between 7 days and one month of life, referred from the different hospitals of the Spanish Health System, will be included in the study.\n* No distinction will be made on the basis of race or ethnic group to which the participants belong.\n* Any patient will be discriminated due to distance from their place of residence.\n* Participants must agree to attend regular check-ups.\n* All patients who agree to be part of the experimental study must previously sign the specific informed consent designed for this purpose.\n\nExclusion Criteria:\n\n* Caregivers who are not fluent in the Spanish language will be excluded in order to understand and assimilate all the instructions provided for treatment compliance.\n* Patients who do not comply with the regimen of visits to the orthodontic department, and for whom a correct control of the evolution of the treatment cannot be guaranteed, will be excluded from the study.\n* Lack of collaboration or non-compliance with the use of the clear aligners will also be considered grounds for exclusion.\n* Patients with soft tissue bands should also be excluded from our study.","7 Days","1 Month",{"count":63,"type":21},30,"INTERVENTIONAL",[66],"NA","Since the appearance of presurgical infant orthopedic (PSIO) as a treatment for patients with cleft lip and palate ( CLP) , numerous techniques have been described with the aim of aligning the displaced alveolar segments and restoring the position of the lateral cartilage, thus improving the results of primary surgery. Currently, the most used technique in the different protocols is the nasoalveolar molding (NAM) described by Grayson, from which variants and modifications have emerged in order to improve its results and provide greater comfort for both the patient and their caregivers.\n\nHowever, the main drawback of traditional acrylic NAM is the need for sequential addition of acrylic to reduce the size of the indentation. These weekly adjustments consume time and resources for the caregiver and the orthodontist. Likewise, it has been observed that acrylic resin can cause inflammation, irritation and gingival ulceration due to excessive pressure.\n\nPSIO treatment in newborns is a complex procedure that could benefit from simplification through digitization, providing accuracy and precision, avoiding risks such as respiratory obstruction and cyanosis that can be produced by taking impressions with alginates or silicones, most of them needing to be performed under general anesthesia.\n\nUntil now, infant care has been left out of such digitization, despite the fact that the majority of babies who need early orthodontic treatment often suffer from craniofacial disorders. However, in recent years numerous advances have been made in this type of treatment, both in taking records, and in the application of more physiological, lighter and constant forces, providing greater comfort, better acceptance and less pain for the patient . These changes represent a great advance applicable to patients with CLP.",[26,25],[70,71,72],"\"cleft lip\"","\" Cleft palate\"","\"presurgical orthopedics\"","2025-04-22",{"date":75,"type":44},"2025-04-25",{"date":77,"type":21},"2025-11-21",{"date":79,"type":21},"2028-11",{"name":81,"class":51},"Universidad Complutense de Madrid",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":64,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100584166","phase-2-evaluation-of-a-novel-nasal-conformer-in-pediatric-patients-100584166","NCT06885801","Evaluation of a Novel Nasal Conformer in Pediatric Patients","Inclusion Criteria:\n\n* Patient's undergoing primary cleft lip repair or release of nasal scarring\n\nExclusion Criteria:\n\n* patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate","18 Years",{"count":90,"type":21},20,[92],"PHASE2","This study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. This will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. This study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.",[26,95],"Nasal Surgical Procedures","2025-03-13",{"date":98,"type":44},"2025-03-20",{"date":100,"type":21},"2025-06-01",{"date":102,"type":21},"2030-12-01",{"name":104,"class":51},"East Tennessee Children's Hospital",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":123,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100178744","genetics-of-reproductive-disorders-including-kallmann-syndrome-and-cleft-lip-andor-palate-100178744","NCT01601171","Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and\u002For Palate","The Genetics of Neuroendocrine Reproductive Disorders and of the Cleft Lip and\u002For Palate","Inclusion Criteria:(any of the following conditions)\n\n* hypogonadotropic hypogonadism\n* Kallmann syndrome\n* adult-onset hypogonadotropic hypogonadism\n* hypothalamic amenorrhea\n* polycystic ovarian syndrome\n* primary gonadal failure\n* precocious puberty\n* cleft lip\u002Fpalate\n* family members of the above groups\n\nExclusion Criteria:\n\n* acute illness\u002Fhospitalization\n* pituitary tumors\n* iron overload (hemochromatosis)\n* infiltrative diseases (sarcoidosis)\n* chronic alcohol abuse\n* illicit drug use\n* anabolic steroid abuse",true,{"count":114,"type":21},2000,"The purpose of this study is to explore the genetic basis of reproductive disorders and cleft lip and\u002For palate.",[117,118,119,120,121,122,25,26],"Kallmann Syndrome","Hypogonadotropic Hypogonadism","Hypothalamic Amenorrhea","Polycystic Ovarian Syndrome","Precocious Puberty","Cleft Lip and Palate",[124,125,126,127,33,34,128,129],"GnRH deficiency","hypogonadism","anosmia","infertility","cryptorchidism","microphallus","RECRUITING","2022-06-17",{"date":133,"type":44},"2022-06-21",{"date":135,"type":4},"2012-03",{"date":137,"type":21},"2030-03",{"name":139,"class":51},"Centre Hospitalier Universitaire Vaudois",1]