Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT01660867
Status:
WITHDRAWN
Last Update Posted:
2018-01-09
First Post:
2012-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'there was no eligible patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-06', 'studyFirstSubmitDate': '2012-08-03', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hospital admission within 7 days after the day of enrollment', 'timeFrame': 'within 7 days', 'description': 'hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)'}], 'secondaryOutcomes': [{'measure': 'RDAI score', 'timeFrame': 'baseline, between nebulizer, 60min, 120min, 180min, 240min', 'description': 'RDAI score'}, {'measure': 'respiratory rate', 'timeFrame': 'baseline, between nebulizer, 60min, 120min, 180min, 240min', 'description': 'respiratory rate'}, {'measure': 'Heart rate', 'timeFrame': 'baseline, between nebulizer, 60min, 120min, 180min, 240min', 'description': 'Heart rate'}, {'measure': 'Oxygen saturation', 'timeFrame': 'baseline, between nebulizer, 60min, 120min, 180min, 240min', 'description': 'Oxygen saturation'}, {'measure': 'unplanned revisit and admission rate after revisit', 'timeFrame': 'in 7days', 'description': 'unplanned revisit admission rate after revisit'}]}, 'conditionsModule': {'keywords': ['hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone'], 'conditions': ['Acute Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, controlled, double-blinded, clinical trial\n\nSubject : 3mo \\~ 24mo. aged infants with bronchiolitis\n\nThe effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.', 'detailedDescription': 'Randomly assigned to one of three groups\n\n* Group I : nebulized epinephrine + 0.9% saline + placebo\n* Group II : nebulized epinephrine + 3% saline + placebo\n* Group III : nebulized epinephrine + 0.9% saline + dexamethasone\n\nGroup I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone.\n\nThe primary outcome is hospital admission within 7 days after the day of enrollment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3mo \\~ 24mo aged patients with bronchiolitis visit to emergency departments\n* RDAI score 4-15\n\nExclusion Criteria:\n\n* \\< 3mo, \\> 24mo\n* infants who had received oral or inhaled corticosteroids during the preceding 2 weeks\n* infants with a previous episode of wheezing or a diagnosis of asthma\n* any chronic cardiopulmonary disease\n* immunodeficiency\n* infants needed intubation\n* infants with a previous history of apnea or intubation\n* infants with side effect of dexamethasone\n* infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation'}, 'identificationModule': {'nctId': 'NCT01660867', 'briefTitle': 'Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department', 'orgStudyIdInfo': {'id': 'Bronchiolitis_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '0.9% saline + oral placebo', 'description': 'nebulized epinephrine + 0.9% saline + placebo =\\> epinephrine + 0.9% saline', 'interventionNames': ['Drug: 0.9% saline + oral dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': '3% saline + oral placebo', 'description': 'nebulized epinephrine + 3% saline + placebo =\\> nebulized epinephrine + 3% saline', 'interventionNames': ['Drug: 3% saline + oral placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.9% saline + oral dexamethasone', 'description': 'nebulized epinephrine + 0.9% saline + dexamethasone =\\> nebulized epinephrine + 0.9% saline', 'interventionNames': ['Drug: 0.9% saline + oral dexamethasone']}], 'interventions': [{'name': '3% saline + oral placebo', 'type': 'DRUG', 'description': 'nebulized epinephrine + 3% saline + placebo =\\> nebulized epinephrine + 3% saline', 'armGroupLabels': ['3% saline + oral placebo']}, {'name': '0.9% saline + oral dexamethasone', 'type': 'DRUG', 'description': 'nebulized epinephrine + 0.9% saline + dexamethasone =\\> nebulized epinephrine + 0.9% saline', 'armGroupLabels': ['0.9% saline + oral dexamethasone', '0.9% saline + oral placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jin Hee Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}