Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2026-01-18 @ 10:55 PM
Study NCT ID:
NCT06558461
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2024-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulised 3% Hypertonic Saline in Infants With Acute 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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled open-label parallel-arm clinical trial, with allocation 1:1, was conducted to investigate whether nebulizing 3% hypertonic saline will improve clinical symptoms and reduce the length of hospital stay in bronchiolitis compared with the control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.', 'timeFrame': 'three days', 'description': 'The clinical severity score is a validated, self-reported instrument assessing clinical severity over treatment. Possible scores range from 0 (mild) to 12 (severity).'}], 'secondaryOutcomes': [{'measure': 'Shorten the mean length of hospital stays in infants with bronchiolitis after treatment with nebulized 3% hypertonic saline.', 'timeFrame': 'From admission to discharge, up to 14 days', 'description': 'The mean length of hospital stays is the days from admission to discharge of all participants.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchiolitis', '3% hypertonic saline'], 'conditions': ['Acute Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis.', 'detailedDescription': 'Bronchiolitis is the most prevalent disease in infants, especially children younger than two years old. Clinical manifestations vary from mild to severe, even life-threatening respiratory failure. Airway oedema and mucus plugging are the principal pathological features in infants with acute bronchiolitis. Nebulising 3% hypertonic saline solution may reduce these pathological changes, but the evidence remains equivocal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pediatric patients diagnosed with acute bronchiolitis from 1 to 24 months old at Can Tho Children's Hospital.\n\nExclusion Criteria:\n\n* Family members do not agree to let the child participate in the study.\n* Severe respiratory failure required mechanical ventilation.\n* The patient left on his own during treatment."}, 'identificationModule': {'nctId': 'NCT06558461', 'briefTitle': 'Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Can Tho University of Medicine and Pharmacy'}, 'officialTitle': "Evaluating the Efficacy of Nebulised 3% Hypertonic Saline for Acute Bronchiolitis in Infants: A Study at Can Tho Children's Hospital, 2022-2024", 'orgStudyIdInfo': {'id': '173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3% hypertonic saline', 'description': 'Children will receive standard medical care coordinating with nebulizing 3% hypertonic saline in the treatment of bronchiolitis. They received 4ml of 3% Sodium chloride, nebulized three times daily until discharge.', 'interventionNames': ['Drug: 3% Sodium Chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Children will only receive standard medical care.', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': '3% Sodium Chloride', 'type': 'DRUG', 'description': '4ml nebulized three times daily', 'armGroupLabels': ['3% hypertonic saline']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Standard care', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '900000', 'city': 'Can Tho', 'country': 'Vietnam', 'facility': "Can Tho Children's Hospital", 'geoPoint': {'lat': 10.03711, 'lon': 105.78825}}], 'overallOfficials': [{'name': 'Van VuTuong Le, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Can Tho University of Medicine and Pharmacy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'All collected individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Can Tho University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}