Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-29 @ 9:59 AM
Study NCT ID:
NCT03663660
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2018-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Organizational Infrastructure Pediatric Plan in Bronchiolitis Epidemics
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1636}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall hospital length of stay', 'timeFrame': '1 year', 'description': 'Overall hospital length of stay'}], 'secondaryOutcomes': [{'measure': 'Hospitalization rate in ICU', 'timeFrame': '1 year', 'description': 'Rate of hospitalization in intensive care unit'}, {'measure': 'Readmissions within 30 days after hospital discharge', 'timeFrame': '30 days', 'description': 'Number of readmissions in our hospital in the 30 days after hospital discharge'}, {'measure': 'Transfer rate between units', 'timeFrame': '1 year', 'description': 'Transfer rate between units'}, {'measure': 'Cost of the OIPP implementation in our institution', 'timeFrame': '1 year', 'description': 'Cost of the OIPP implementation in our institution'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchiolitis', 'Health care', 'Organizational change', 'children', 'Epidemic', 'cost'], 'conditions': ['Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '31378693', 'type': 'DERIVED', 'citation': 'Lavilledieu D, Abassi H, Mercier G, Guiraud M, Chaffaut GD, Milesi C, Cambonie G, Gavotto A, Jeziorski E, Amedro P. Implementation of an organizational infrastructure paediatric plan adapted to bronchiolitis epidemics. J Infect Public Health. 2020 Feb;13(2):167-172. doi: 10.1016/j.jiph.2019.07.007. Epub 2019 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'Acute bronchiolitis is a frequent respiratory viral infection of infants, responsible for 460,000 new cases per year in France. Over the years, the number of hospitalizations during the epidemic season appears to be increasing. Bronchiolitis epidemics lead to recurrent hospital disruption. The current trend towards a reduction of hospital beds is exacerbating the pressure on bronchiolitis epidemics on healthcare systems.\n\nIn this context, the pediatric departments of Montpellier University Hospital, France, designed in 2014 a common organizational infrastructure pediatric plan (OIPP) to to adapt to these multiple constraints while respecting the quality of care.\n\nThis plan includes a referral flowchart for hospitalized children, an increase in medical and paramedical staff and a restructuring of the pediatric units, with a specific stratification into 4 levels of care.\n\nThe study aims to assess the impact of our OIPP on the overall length of stay for children hospitalized for bronchiolitis. The investigator also intend to measure the impact of the OIPP on the length of stay within each unit, the number of transfers from one unit to the other and the number of readmissions within 30 days after hospital discharge. The cost of the implementation of the OIPP in the structure will be analyzed.', 'detailedDescription': 'The investigator compared data between two periods of time, e.g. the two consecutive years before the beginning of the OIPP (winters 2012-2013 and 2013-2014) and two first years after the beginning of the OIPP (winters 2015-2016 and 2016-2017).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chidren under 2 years hospitalized for bronchiolitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* age \\< 2 years\n* hospitalization for bronchiolitis\n\nExclusion criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03663660', 'acronym': 'OIPP', 'briefTitle': 'Organizational Infrastructure Pediatric Plan in Bronchiolitis Epidemics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Design of an Organizational Infrastructure Pediatric Plan to Deal With Bronchiolitis Epidemics: Impact on Length of Stay and Quality of Care in a Tertiary Care Regional Hospital', 'orgStudyIdInfo': {'id': 'RECHMPL18_0174'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'before the OIPP', 'description': 'Period 1 : Children hospitalized before the OIPP implementation'}, {'label': 'after the OIPP implementation', 'description': 'Period 2 :Children hospitalized after the OIPP implementation', 'interventionNames': ['Other: Organizational infrastructure pediatric plan (OIPP)']}], 'interventions': [{'name': 'Organizational infrastructure pediatric plan (OIPP)', 'type': 'OTHER', 'description': 'Restructuration of the hospital sectors with a stratification of health care into 4 levels.', 'armGroupLabels': ['after the OIPP implementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Pascal AMEDRO, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}