Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-03-10 @ 6:52 PM
Study NCT ID:
NCT03015051
Status:
TERMINATED
Last Update Posted:
2020-09-04
First Post:
2016-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula vs Low Flow Oxygen Therapy in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Difficulty in recruiting subjects who meet the inclusion/exclusion criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hours of oxygen therapy', 'timeFrame': 'up to 5 days'}], 'secondaryOutcomes': [{'measure': 'Number of subject admitted in intensive care unit', 'timeFrame': 'up to 5 days'}, {'measure': 'Number of patients needing intubation', 'timeFrame': 'up to 5 days'}, {'measure': 'Days of parenteral hydration or nasogastric enteral feeding', 'timeFrame': 'up to 5 days', 'description': 'Number of days'}, {'measure': 'Adverse events', 'timeFrame': 'up to 15 days', 'description': 'Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bronchiolitis', 'High flow nasal cannula', 'Oxygen therapy'], 'conditions': ['Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'Bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of the techniques of administration of oxygen in bronchiolitis is represented by the high flow (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces breathing load and allows for better nutrition. The main aim of therapy with high flows is to reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot study of 19 subjects comparing HFNC with oxygen administered via "head box". The oxygen saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs 96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available evidence is insufficient to determine the effectiveness of HFNC.\n\nThe aim of this study is to evaluate in a large number of cases the effectiveness of treatment with high flow versus standard treatment, in children with bronchiolitis referred to a Pediatric Emergency Department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of bronchiolitis\n* age \\>28 days and \\<6 months\n* Oxygen saturation (SaO2) \\<92%\n* respiratory rate \\>60 breaths/min\n* dyspnea with respiratory distress assessment instrument (RDAI) score ≥8\n* daily milk or food intake less than 2/3 than normally assumed\n\nExclusion Criteria:\n\n* chronic diseases or syndromes\n* respiratory diseases (i.e. bronchopulmonary dysplasia)\n* heart diseases\n* preterm birth (before 36 weeks of gestational age)'}, 'identificationModule': {'nctId': 'NCT03015051', 'briefTitle': 'High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis', 'orgStudyIdInfo': {'id': 'High flow RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High flow', 'description': 'High flow (2 L/kg/min) nasal cannula oxygen therapy', 'interventionNames': ['Drug: Oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low flow', 'description': 'Low flow (max 3 L/min) oxygen therapy', 'interventionNames': ['Drug: Oxygen']}], 'interventions': [{'name': 'Oxygen', 'type': 'DRUG', 'armGroupLabels': ['High flow', 'Low flow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40133', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Ospedale Maggiore', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '47100', 'city': 'Forlì', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Ospedale Morgagni-Pierantoni', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'zip': '48100', 'city': 'Ravenna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Ospedale Ravenna AUSL Romagna', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '33170', 'city': 'Pordenone', 'state': 'Friuli Venezia Giulia', 'country': 'Italy', 'facility': 'Ospedale Santa Maria degli Angeli', 'geoPoint': {'lat': 45.95689, 'lon': 12.66051}}, {'zip': '34137', 'city': 'Trieste', 'state': 'Friuli Venezia Giulia', 'country': 'Italy', 'facility': 'Pediatric Emergency Department, IRCCS Burlo Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '00165', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ospedale Pediatrico IRCCS Bambino Gesú', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '16120', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'Istituto G. Gaslini', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '20900', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fondazione MBBM c/o Ospedale San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '86170', 'city': 'Campobasso', 'state': 'Molise', 'country': 'Italy', 'facility': 'Ospedale A. Cardarelli', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}, {'zip': '10100', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Ospedale Infantile Regina Margherita', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '28992', 'city': 'Verbania', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Ospedale Castelli', 'geoPoint': {'lat': 45.92136, 'lon': 8.55183}}, {'zip': '07026', 'city': 'Olbia', 'state': 'Sardinia', 'country': 'Italy', 'facility': 'Ospedale Giovanni Paolo II', 'geoPoint': {'lat': 40.92337, 'lon': 9.49802}}, {'zip': '62100', 'city': 'Macerata', 'state': 'The Marches', 'country': 'Italy', 'facility': 'Ospedale Provinciale di Macerata', 'geoPoint': {'lat': 43.29789, 'lon': 13.45293}}, {'zip': '60019', 'city': 'Senigallia', 'state': 'The Marches', 'country': 'Italy', 'facility': 'Ospedale Principe di Piemonte Area Vasta 2', 'geoPoint': {'lat': 43.71626, 'lon': 13.20882}}, {'zip': '35100', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Egidio Barbi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS Burlo Garofolo, Trieste, Italy'}, {'name': 'Stefania Norbedo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Burlo Garofolo, Trieste, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinical Epidemiology and Public Health Research Unit', 'investigatorFullName': 'Luca Ronfani', 'investigatorAffiliation': 'IRCCS Burlo Garofolo'}}}}