[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658309":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":26,"interventions":37,"overallOfficials":17,"centralContacts":17,"locations":17,"responsibleParty":43,"collaborators":17,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":17,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":17,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":17,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":17},{"fullName":5,"class":6},"Hanoi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Post-intervention nasal symmetry","Columellar deviation: This measure is assessed by the angle formed between the tangent line passing through the nasal base and the line passing through the midpoint of the columella. The value ranges from 0° to 90°, with a larger angle indicating a better outcome.\n\nDegree of alar collapse on the affected side compared with the unaffected side: This measure is assessed as the ratio of the alar height on the affected side to the alar height on the unaffected side. The value ranges from 0% to 100%, with a higher ratio indicating a better outcome.","at 1 week, 3 months, and 6 months postoperatively",[14],{"measure":15,"description":16,"timeFrame":12},"convenience and ease of use of the retainer","Adverse effects: This variable determines the presence or absence of adverse effects associated with the use of the device (e.g., whether the child is irritable or fussy, and whether there is redness or an inflammatory reaction at the device-skin contact area).\n\nConvenience and satisfaction: Scores are rated on a 1-5 scale, corresponding to very dissatisfied - dissatisfied - neutral - satisfied - very satisfied, respectively. A higher score indicates greater convenience and satisfaction.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":24},"SINGLE",[25],"OUTCOMES_ASSESSOR",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Intervention arm: customized nostril retainer","EXPERIMENTAL","Participants who use a customized nostril retainer after unilateral cleft lip repair.",[32],"Device: customized nostril retainer",{"label":34,"type":35,"description":36,"interventionNames":17},"Control arm - Non-customized nostril retainer","NO_INTERVENTION","Participants who do not use a customized nostril retainer after unilateral cleft lip repair",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":17},"DEVICE","customized nostril retainer","Participants will undergo unilateral cleft lip repair and will then be assigned to either receive or not receive a customized nostril retainer.",[28],{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Dinh Dieu Hong","Principal Investigator","100658309","study-on-the-supportive-effect-of-personalized-nostril-retainer-in-unilateral-cleft-lip-surgery-100658309",false,"NCT07850180","Study on the Supportive Effect of Personalized Nostril Retainer in Unilateral Cleft Lip Surgery","Inclusion Criteria:\n\n* Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair.\n* No local infection or inflammation.\n* No associated congenital anomalies other than cleft lip and\u002For cleft palate.\n\nExclusion Criteria:\n\n* Participants who do not meet any one of the inclusion criteria.\n* Patients who are unable to attend follow-up visits.\n* Families or legal guardians who refuse to participate in the study.","ALL","3 Months","18 Months",{"count":57,"type":58},40,"ESTIMATED","INTERVENTIONAL",[61],"NA","The objective of this clinical trial is to evaluate the supportive effectiveness of a customized nostril retainer in unilateral cleft lip repair at several hospitals in Hanoi. The main question that this trial aims to answer is: Does a customized nostril retainer help improve the aesthetic reconstruction of the nose in children following unilateral cleft lip repair?\n\nThe researchers will compare the use and non-use of a customized nostril retainer to determine whether the retainer is effective in supporting the aesthetic reconstruction of the nose.\n\nParticipants will be divided into two groups (the intervention group and the control group):\n\nStudy population: Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair.\n\nIntervention group: Participants who use a customized nostril retainer after unilateral cleft lip repair.\n\nControl group: Participants who do not use a customized nostril retainer after unilateral cleft lip repair.\n\nFollow-up: Participants will return for follow-up visits at 1 week, 3 months, and 6 months after surgery.\n\nOutcome assessment: Nasal aesthetics will be evaluated at each follow-up visit, along with the convenience and ease of use of the retainer, assessed through interviews with caregivers.",[64],"Unilateral Cleft Lip",[66,40],"unilateral cleft lip","NOT_YET_RECRUITING","2026-09-29",{"date":70,"type":71},"2026-09-30","ACTUAL",{"date":73,"type":58},"2026-10-01",{"date":75,"type":58},"2027-07-31",{"name":5,"class":6}]