Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-28 @ 11:58 AM
Study NCT ID:
NCT06112132
Status:
UNKNOWN
Last Update Posted:
2024-02-08
First Post:
2023-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Observatory of Children Hospitalized for Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients hospitalized for bronchiolitis', 'timeFrame': '1 year', 'description': 'Assessment of the number of hospitalized bronchiolitis in the context of routine immunization with Nirsevimab'}], 'secondaryOutcomes': [{'measure': 'Proportion of RSV vs non-RSV associated to bronchiolitis hospitalizations', 'timeFrame': '1 year', 'description': 'Assessment of proportion of RSV vs non- RSV associated bronchiolitis hospitalizations'}, {'measure': 'Proportion of other viruses associated to bronchiolitis hospitalizations.', 'timeFrame': '1 year', 'description': 'Assessment of the proportion of other viruses (isolated or associated with RSV) associated bronchiolitis hospitalizations'}, {'measure': 'Proportion of patients immunized with Nirsevimab among children hospitalized for bronchiolitis', 'timeFrame': '1 year', 'description': 'Description of immunization status with Nirsevimab of hospitalized patients for bronchiolitis overall (RSV+, RSV-) and other viruses (isolated or associated with RSV)'}, {'measure': 'Proportion of demographics and clinical characteristics of patients hospitalized for bronchiolitis overall', 'timeFrame': '1 year', 'description': 'Description of demographics (including immunization status with Nirsevimab) and clinical characteristics of patients hospitalized for bronchiolitis overall ( RSV+, RSV-) and other viruses (isolated or associated with RSV)'}, {'measure': 'Proportion of demographics, clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support', 'timeFrame': '1 year', 'description': 'Description of demographics (including immunization status with Nirsevimab), clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support'}, {'measure': 'Length of hospital stay of children with bronchiolitis overall in France', 'timeFrame': '1 year', 'description': 'Assesment of the duration of hospitalization for bronchiolitis overall (RSV+, RSV-) in France'}, {'measure': 'Length of hospital stay of children with bronchiolitis in France according to immunization status with Nirsevimab', 'timeFrame': '1 year', 'description': 'Assesment of the duration of hospitalization for bronchiolitis according to immunization status with Nirsevimab'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '39589139', 'type': 'DERIVED', 'citation': 'Jeziorski E, Ouziel A, Cotillon M, Bridonneau C, Bizot E, Basse C, Portefaix A, Dubos F, Bechet S, Domitien L, Jaillet C, Abrudan S, Kramer R, Gajdos V, Launay E, Basmaci R, Gillet Y, Cohen R, Levy C. Impact of Nirsevimab on Respiratory Syncytial Virus Bronchiolitis in Hospitalized Infants: A Real-World Study. Pediatr Infect Dis J. 2025 Apr 1;44(4):e124-e126. doi: 10.1097/INF.0000000000004630. Epub 2024 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children for bronchiolitis associated or not to RSV or other viruses (isolated or associated with RSV)', 'detailedDescription': 'The aim of this surveillance is to observe and describe the cases hospitalized for bronchiolitis in the 2023/2024 season in the context of routine immunization with Nirsevimab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children hospilalized for bronchiolitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children under 12 months of age\n* In one of the 6 study sites\n* From October 15, 2023\n* For acute bronchiolitis defined according to current national and international recommendations\n* Hospitalized from the pediatric emergency department.\n\nExclusion Criteria:\n\n\\- Refusal to participate by patient relative or legal representative'}, 'identificationModule': {'nctId': 'NCT06112132', 'acronym': 'OVNI', 'briefTitle': 'National Observatory of Children Hospitalized for Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Association Clinique Thérapeutique Infantile du val de Marne'}, 'officialTitle': 'National Observatory of Children Hospitalized for Bronchiolitis', 'orgStudyIdInfo': {'id': 'OVNI'}}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Levy Corinne', 'role': 'CONTACT', 'email': 'corinne.levy@activ-france.fr', 'phone': '148850404', 'phoneExt': '+33'}, {'name': 'Béchet Stéphane', 'role': 'CONTACT', 'email': 'stephane.bechet@activ-france.fr', 'phone': '1 48 85 96 68', 'phoneExt': '+33'}], 'facility': 'ACTIV', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Levy Corinne', 'role': 'CONTACT', 'email': 'corinne.levy@activ-france.fr', 'phone': '1 48 85 04 04', 'phoneExt': '+33'}, {'name': 'Bechet Stephane', 'role': 'CONTACT', 'email': 'stephane.bechet@activ-france.fr', 'phone': '1 48 85 96 68', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Levy Corinne', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Association Clinique Thérapeutique Infantile du val de Marne'}, {'name': 'Jeziorski Eric', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Montpellier, Service Urgence et Post-urgences pédiatrique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}