Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-24 @ 12:52 AM
Study NCT ID:
NCT03095495
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2017-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-08', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of Pediatric Intensive Care Unit (PICU) admissions', 'timeFrame': 'Through study completion, an average of 3 year', 'description': 'The rate of Pediatric Intensive Care Unit admissions'}], 'secondaryOutcomes': [{'measure': 'Mean length of stay (LOS)', 'timeFrame': 'Through study completion, an average of 3 year', 'description': 'Geometric mean length of stay in the short stay unit'}, {'measure': 'Bronchiolitis Severity Score (BSS)', 'timeFrame': 'Up to 72 hours', 'description': 'Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours'}, {'measure': 'Percentage of revisit, infirmary short-stay and admission to the hospital or PICU', 'timeFrame': '2 weeks after discharge', 'description': 'Percentage of revisit, infirmary short-stay and admission to the hospital or PICU for the same illness on follow up for two weeks post discharge'}, {'measure': 'Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)', 'timeFrame': 'Up to 72 hours', 'description': 'Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours'}, {'measure': 'Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED', 'timeFrame': '1 hour after starting of rescue HHHFNC', 'description': 'Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heated Humidified High Flow Nasal Cannula (HHHFNC)', 'Low Flow Nasal Cannula', 'Bronchiolitis', 'Respiratory Syncytial Virus (RSV)', 'Respiratory Failure', 'High Flow Nasal Cannula (HFNC)', 'Lung Diseases, Obstructive'], 'conditions': ['Bronchiolitis', 'Respiratory Syncytial Virus (RSV)']}, 'descriptionModule': {'briefSummary': 'The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment.', 'detailedDescription': 'Setting:\n\nThe study will be conducted between June 2017 and June 2020 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis with positive RSV test will be eligible for the study.\n\nProcedure:\n\nEligible patients will be enrolled after obtaining written consent. For patients who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized in one of the study arms. Adverse effects in each group will be carefully monitored and documented.\n\nStudy Intervention:\n\nPatients will be randomized into two treatment arms\n\nGroup 1: Early HHHFNC Group Patients in this group will be treated by using heated humidified high flow oxygen /air via nasal cannula; investigators will keep the patient on HHHFNC until he/she becomes clinically ready for discharge.\n\nGroup 2: Standard Therapy and Rescue HHHFNC Group:\n\npatients in this group will be treated by usual therapy,investigators will use low flow nasal cannula oxygen therapy only if oxygenation needed to maintain Oxygen saturation (SpO2) ≥ 92% , if the patient deteriorate and require ICU, rescue HHHFNC will be started before admission to the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously healthy infants with age 0-3 months and gestational age ≥30 weeks admitted to the short stay unit with RSV positive bronchiolitis and clinical severity score ≥4 on Wang clinical severity scale.\n\nExclusion Criteria:\n\n1. Gestational age less than 30 weeks.\n2. Previous history of wheezing.\n3. Use of steroid within 48 hours of presentation.\n4. History of chronic lung disease.\n5. Infants admitted directly to ICU.\n6. Prior invasive or non-invasive ventilatory support.\n7. Tracheostomy.\n8. Nasogastric tubes in situ on admission.\n9. Upper airway abnormality (like choanal atresia and midfacial anomalies).\n10. Immunodeficient children.\n11. History of cardiac disease, renal disease or liver disease.\n12. History of neuromuscular disorder.'}, 'identificationModule': {'nctId': 'NCT03095495', 'briefTitle': 'High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamad Medical Corporation'}, 'officialTitle': 'Heated Humidified High Flow Nasal Cannula (HHHFNC) For Acute Moderate to Severe RSV-Bronchiolitis in Infants Younger Than 3 Months Old: Early Versus Rescue', 'orgStudyIdInfo': {'id': '16036/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early use of HHHFNC', 'description': 'Heated Humidified High Flow Nasal Cannula', 'interventionNames': ['Device: Heated Humidified High Flow Nasal Cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy and Rescue HHHFNC', 'description': 'Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU', 'interventionNames': ['Device: Heated Humidified High Flow Nasal Cannula', 'Device: Standard Therapy (Low Flow Nasal Cannula)']}], 'interventions': [{'name': 'Heated Humidified High Flow Nasal Cannula', 'type': 'DEVICE', 'description': 'HHHFNC therapy is a simple to use system that delivers warm and moist air/oxygen mixture at high flow rates that generate positive airway pressure', 'armGroupLabels': ['Early use of HHHFNC', 'Standard Therapy and Rescue HHHFNC']}, {'name': 'Standard Therapy (Low Flow Nasal Cannula)', 'type': 'DEVICE', 'description': 'will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU', 'armGroupLabels': ['Standard Therapy and Rescue HHHFNC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Doha', 'country': 'Qatar', 'facility': 'Alsadd Pediatric Emergency Center', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'overallOfficials': [{'name': 'Khalid Alansari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamad Medical Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sidra Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}