Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-28 @ 5:21 PM
Study NCT ID:
NCT00125450
Status:
COMPLETED
Last Update Posted:
2008-05-28
First Post:
2005-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001990', 'term': 'Bronchiolitis, Viral'}], 'ancestors': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-26', 'studyFirstSubmitDate': '2005-07-29', 'studyFirstSubmitQcDate': '2005-07-29', 'lastUpdatePostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate', 'timeFrame': 'obtention'}], 'secondaryOutcomes': [{'measure': 'Safety of the forced expiratory technique', 'timeFrame': 'during hospitalisation'}, {'measure': 'Comparison of pulse oxymetry before/after chest physiotherapy', 'timeFrame': 'during hospitalisation'}, {'measure': 'Quality of Life Scale', 'timeFrame': 'on discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Bronchiolitis', 'Chest Physiotherapy', 'Forced Expiratory Techniques', 'Double Blind Trial', 'Children', 'Pediatric', 'RESPIRATORY SYNCYTIAL VIRUS'], 'conditions': ['Viral Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '15846736', 'type': 'BACKGROUND', 'citation': 'Perrotta C, Ortiz Z, Roque M. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004873. doi: 10.1002/14651858.CD004873.pub2.'}, {'pmid': '37010196', 'type': 'DERIVED', 'citation': 'Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.'}, {'pmid': '20927359', 'type': 'DERIVED', 'citation': 'Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.'}], 'seeAlsoLinks': [{'url': 'http://www.aphp.fr', 'label': 'sponsor web site'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.', 'detailedDescription': 'Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the majority of hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence against the effectiveness of chest physiotherapy with vibration and postural drainage techniques has been described but forced expiratory technique, as described in France, has never been evaluated.\n\nThe investigators hypothesised that forced expiratory technique was able to reduce the duration of respiratory distress.\n\nComparison(s): The investigators compare physiotherapy with forced expiratory techniques to simple aspiration of naso-pharyngeal secretions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '15 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child aged 15 days to 24 months\n* First acute bronchiolitis\n* Indication of hospitalisation\n* One or more of these criteria : toxic aspect; apnea or cyanosis; respiratory rate \\> 60/min; pulse oxymetry \\< 95%; alimentary intake \\< 2/3 of the needs.\n\nExclusion Criteria:\n\n* Prematurity (gestational age \\< 32 weeks)\n* Brondysplasia\n* Chronic lung disease or congenital heart disease\n* Respiratory distress necessitating admission in the Pediatric Intensive Care Unit (PICU)\n* 3 or more chest physiotherapy procedures since hospitalisation\n* Parental refusal\n* Any chest physiotherapy contra-indication'}, 'identificationModule': {'nctId': 'NCT00125450', 'acronym': 'BRONKINOU', 'briefTitle': 'Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers', 'orgStudyIdInfo': {'id': 'P030421'}, 'secondaryIdInfos': [{'id': 'AOM 03123'}, {'id': 'DGS 2004/0276'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Chest Physiotherapy with Forced Expiratory Technique', 'interventionNames': ['Procedure: Chest Physiotherapy with Forced Expiratory Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Aspiration', 'interventionNames': ['Procedure: Nasopharyngeal Aspiration']}], 'interventions': [{'name': 'Chest Physiotherapy with Forced Expiratory Technique', 'type': 'PROCEDURE', 'otherNames': ['A. Chest Physiotherapy with Forced Expiratory Technique'], 'description': 'Chest Physiotherapy with Forced Expiratory Technique', 'armGroupLabels': ['A']}, {'name': 'Nasopharyngeal Aspiration', 'type': 'PROCEDURE', 'description': 'Nasopharyngeal Aspiration', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93140', 'city': 'Bondy', 'country': 'France', 'facility': 'Jean Verdier Hospital', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Ambroise Paré Hospital', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Antoine Béclère Hospital - Pediatric Department', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Kremlin Bicetre Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Trousseau Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Necker - Enfants Malades Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Robert Debré Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Vincent Gajdos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Philippe Labrune, MD - PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association des Réseaux Bronchiolite', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Marc LEGRAND', 'oldOrganization': 'Department Clinical Research of Developpemnt'}}}}