[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529701":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":40,"responsibleParty":145,"collaborators":30,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":149,"sex":155,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":30,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"University Hospital, Brest","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Physiomer","EXPERIMENTAL","It is a sterile, isotonic seawater-based solution, with a concentration equivalent to 9 g\u002FL sodium chloride. This solution is packaged in 5 mL single-dose units.\n\nIt is a Class IIa medical device manufactured by Laboratoire de la mer, and is CE marked.\n\nElectrodialyzed seawater solution is administered via the nasal passage, in line with current recommendations. Dosage varies according to age, and the pressure exerted on the unit dose enables the product to be administered into the nostril.",[13],"Device: Physiomer",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline solution","ACTIVE_COMPARATOR","It is a sterile, isotonic seawater-based solution, with a concentration egal to 0,9 g\u002FL sodium chloride. This solution is packaged in 5 mL single-dose units.\n\nIt is a Class IIa medical device manufactured by GiLBERT, and is CE marked. The saline solution is administered via the nasal passage, in line with current recommendations. Dosage varies according to age, and the pressure exerted on the unit dose enables the product to be administered into the nostril.",[19],"Device: Saline solution",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Infants randomized to the experimental group will be given an electrolyzed seawater solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort:\n\n* Infant \\\u003C 6 months: half a dose to a single dose administered per nostril 8 times a day.\n* Infant \\> 6 months: one single dose administered per nostril 6 times a day.",[9],[26],"Electrodilysed seawater solution",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Infants randomized to the control group will be given a saline solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort:\n\n* Infant \\\u003C 6 months: half a dose to a single dose administered per nostril 8 times a day.\n* Infant \\> 6 months: one single dose administered per nostril 6 times a day.",[15],null,[32,37],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Pierrick CROS, MD","CONTACT","+33298223659","pierrick.cros@chu-brest.fr",{"name":38,"role":34,"phone":30,"phoneExt":30,"email":39},"Léa GAITAN, MD","lea.gaitan@chu-brest.fr",[41,60,72,85,97,109,121,133],{"facility":42,"status":43,"city":44,"state":30,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Brest, University Hospital","RECRUITING","Brest","29609","France","FR",{"type":49,"coordinates":50},"Point",[51,52],-4.48628,48.39029,{"lat":52,"lon":51},[55,57],{"name":33,"role":34,"phone":56,"phoneExt":30,"email":36},"02 98 22 36 59",{"name":58,"role":34,"phone":30,"phoneExt":30,"email":59},"Guillaume DEVERRIERE, MD","guillaume.deverriere@chu-brest.fr",{"facility":61,"status":43,"city":62,"state":30,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Le Mans hospital","Le Mans","72037",{"type":49,"coordinates":65},[66,67],0.20251,48.0021,{"lat":67,"lon":66},[70],{"name":71,"role":34,"phone":30,"phoneExt":30,"email":30},"Aude FORGERON, MD",{"facility":73,"status":74,"city":75,"state":30,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Lille, University hospital","NOT_YET_RECRUITING","Lille","59000",{"type":49,"coordinates":78},[79,80],3.05512,50.63391,{"lat":80,"lon":79},[83],{"name":84,"role":34,"phone":30,"phoneExt":30,"email":30},"François DUBOS, MD",{"facility":86,"status":43,"city":87,"state":30,"zip":88,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Saint-Joseph hospital","Marseille","13008",{"type":49,"coordinates":90},[91,92],5.38107,43.29695,{"lat":92,"lon":91},[95],{"name":96,"role":34,"phone":30,"phoneExt":30,"email":30},"Ania CARSIN, MD",{"facility":98,"status":43,"city":99,"state":30,"zip":100,"country":46,"countryCode":47,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Morlaix hospital","Morlaix","29600",{"type":49,"coordinates":102},[103,104],-3.82792,48.57784,{"lat":104,"lon":103},[107],{"name":108,"role":34,"phone":30,"phoneExt":30,"email":30},"Thomas BRIAND, MD",{"facility":110,"status":43,"city":111,"state":30,"zip":112,"country":46,"countryCode":47,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Nantes, University Hospital","Nantes","44400",{"type":49,"coordinates":114},[115,116],-1.55336,47.21725,{"lat":116,"lon":115},[119],{"name":120,"role":34,"phone":30,"phoneExt":30,"email":30},"Anne-Claire VIGUIE, MD",{"facility":122,"status":43,"city":123,"state":30,"zip":124,"country":46,"countryCode":47,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Rennes, University hospital","Rennes","35033",{"type":49,"coordinates":126},[127,128],-1.67431,48.11109,{"lat":128,"lon":127},[131],{"name":132,"role":34,"phone":30,"phoneExt":30,"email":30},"Tommasco DE GIORGIS, MD",{"facility":134,"status":43,"city":135,"state":30,"zip":136,"country":46,"countryCode":47,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Tours, University hospital","Tours","37000",{"type":49,"coordinates":138},[139,140],0.70398,47.39484,{"lat":140,"lon":139},[143],{"name":144,"role":34,"phone":30,"phoneExt":30,"email":30},"Yves MAROT, MD",{"type":146,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100529701","bronchiolitis-clearance-airways-with-seaserum-100529701",false,"NCT06177197","Bronchiolitis Clearance Airways With Seaserum","Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study","B-CLASS","Inclusion Criteria:\n\n* Infants aged more than 1 month and less than 1 year\n* First episode of acute bronchiolitis\n* Emergency consultation\n* Existence of nasal obstruction\n* Onset of symptoms \\< 48 hours before emergency consultation\n* Outpatient care after emergency consultation\n* Mild to moderate bronchiolitis according to the \\"Haute Autorité de Santé 2019\\" criteria:\n\nRespiratory rate over 1 minute \\>30\u002Fminutes and \\<60\u002Fminute ; Heart rate \\>80\u002Fminutes and \\<180\u002Fminutes; Absence of respiratory pauses; Absence of superficial breathing; Absence of signs of intense respiratory struggle: involvement of the lower intercostal accessory muscles, sternocleidomastoid muscles, thoracoabdominal swinging, or flapping of the wings of the nose; Feeding \\>50% of the usual quantity over 3 consecutive doses; SpO2 \\> 92% during sleep ; \\>94% when awake; \\>2 months corrected age\n\n* Parental consent\n* Affiliate to a social security system\n\nExclusion Criteria:\n\n* Hospitalization (excluding short stay unit) after emergency consultation\n* Oxygen therapy\n* History of prematurity (birth \\<36 weeks of amenorrhea)\n* History of invasive ventilation in the neonatal period\n* History of chronic pulmonary or cardiac pathology\n* History of immune deficiency\n* History of polyhandicap or neuromuscular pathology\n* History of malformative Ear Nose and Throat pathology affecting the upper airways\n* Impossibility of ensuring the follow-up made necessary by participation in this study","ALL","1 Month","1 Year",{"count":159,"type":160},458,"ESTIMATED","INTERVENTIONAL",[163],"NA","The objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year.\n\nB-CLASS study is a multicenter, prospective, controlled, randomized, double label blind.",[166],"Bronchiolitis Acute",[168,169,170],"Infant","Nasopharyngeal decongestion","Bronchiolitis","2025-12-16",{"date":173,"type":174},"2025-12-17","ACTUAL",{"date":176,"type":174},"2025-01-10",{"date":178,"type":160},"2028-12-01",{"name":5,"class":6},8]