[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629375":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":59,"collaborators":18,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":89,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IPV + Manual Respiratory Physiotherapy","EXPERIMENTAL","After the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home.",[13],"Procedure: Intrapulmonary Percussive Ventilation IPV",{"label":15,"type":16,"description":17,"interventionNames":18},"Manual Respiratory Physiotherapy Only","NO_INTERVENTION","no intervention, current practice",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Intrapulmonary Percussive Ventilation IPV",[9],[25,26],"Comfort Cough II®","Percussion Ventilation Device",[28],{"name":29,"affiliation":5,"role":30},"Jessica TAYTARD, MCU-PH","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","+33 (0)1 71 73 87 11","jessica.taytard@aphp.fr",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Elsa SCHWARTZ","00 33 1 71 73 80 26","elsa.schwartz@aphp.fr",[41],{"facility":42,"status":18,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Name Pediatric Pulmonology Department - Armand Trousseau Hospital","Paris","75012","France","FR",{"type":48,"coordinates":49},"Point",[50,51],2.3488,48.85341,{"lat":51,"lon":50},[54,55],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":56,"role":33,"phone":57,"phoneExt":18,"email":58},"Charlotte THEBAULT","00 33 6.65.80.72.55","charlotte.thebault@aphp.fr",{"type":60,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100629375","long-term-use-of-intrapulmonary-percussive-ventilation-for-preventing-hospitalizations-due-to-respiratory-decompensation-in-children-with-multiple-disabilities-100629375",false,"NCT07473856","Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities","Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities: A Multicenter Randomized Controlled Trial.","PERKINE","Inclusion Criteria:\n\n* Polyhandicap defined by:\n\n  * Causal brain injury or lesion occurring before the age of 3 years,\n  * Severe or profound intellectual disability according to DSM IV definition\n  * Motor disability: paraplegia\u002Fquadriplegia, hemiparesis, ataxia, and\u002For extrapyramidal motor disorders,\n  * Gross Motor Function Classification System (GMFCS) score of IV or V,\n  * Functional Independence Measure (FIM) score \\\u003C 55,\n* Age: 1 to 16 years,\n* Hospitalization of the patient with respiratory decompensation (RD),\n* Informed consent from parents\u002Flegal guardians\n\nExclusion Criteria:\n\n* Associated neuromuscular disease\n* Daily use of intrapulmonary percussive ventilation for more than 3 consecutive months within the 6 months prior to inclusion,\n* Daily use of a cough assistance device such as an insufflator-exsufflator for more than 3 consecutive months within the 6 months prior to inclusion,\n* Contraindications for the use of the medical device:\n\n  * Pneumothorax,\n  * Hypotension or hemodynamic instability,\n  * Hemoptysis,\n* Participation in another interventional study.\n* Patients with tracheobronchial collapse during expiration","ALL","1 Year","16 Years",{"count":73,"type":74},146,"ESTIMATED","INTERVENTIONAL",[77],"NA","Chronic respiratory failure is the leading cause of morbidity and mortality in children with multiple disabilities. Musculoskeletal disorders, swallowing disorders and ventilatory control abnormalities lead to progressive respiratory impairment, causing episodes of respiratory decompensation (RD). These are the leading cause of mortality (50 to 80%, average age of death: 21 years) and the cause of repeated hospitalizations.\n\nRespiratory care for these children is therefore a major challenge. In respiratory physiotherapy, this can be achieved through manual techniques and\u002For instrumental techniques such as intrapulmonary percussive ventilation (IPV), which is particularly useful in this population because it does not require active cooperation.\n\nThe main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV at home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone.This is a multicenter, randomized controlled superiority trial with two parallel groups.\n\nAll centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with respiratory decompensation (RD). After consent has been signed by the parents or legal guardians, the patient will be randomized into one of the two study groups:\n\n* Control group: manual respiratory physiotherapy.\n* Intervention group: intrapulmonary Percussive Ventilation (IPV)",[80,81],"Respiratory Decompensation","Multiple Disabilities",[83,84,85,86,87,88],"Polyhandicap","Intrapulmonary Percussive Ventilation","Respiratory distress","Rehospitalization with respiratory decompensation","Quality of life (PolyQol)","Exacerbation management at home","NOT_YET_RECRUITING","2026-03-11",{"date":92,"type":93},"2026-03-16","ACTUAL",{"date":95,"type":74},"2026-03",{"date":97,"type":74},"2029-03",{"name":5,"class":6},1]