Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT00619918
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nebulized Hypertonic Saline for Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'suwu@chla.usc.edu', 'phone': '323-361-6177', 'title': 'Susan Wu', 'organization': "Children's Hospital Los Angeles"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '* Albuterol administered before each study treatment\n* Did not reach subject accrual goals\n* Number of patients recruited from inpatient unit too small to analyze separately'}}, 'adverseEventsModule': {'timeFrame': 'Patient enrollment through duration of hospitalization (average 3.5 days)', 'description': 'The number of participants at risk is different from the number started because one patient randomized to the normal saline group received hypertonic saline.', 'eventGroups': [{'id': 'EG000', 'title': 'Hypertonic Saline', 'description': '3% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge', 'otherNumAtRisk': 231, 'deathsNumAtRisk': 231, 'otherNumAffected': 5, 'seriousNumAtRisk': 231, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Saline', 'description': '0.9% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 8, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ICU admission', 'notes': 'Patients requiring admission or transfer to the PICU or NICU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening cough', 'notes': 'Parent or provider perception of worsening cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Admission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '3% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': '0.9% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge'}], 'classes': [{'title': 'Admitted', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Discharged', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis for this outcome only includes patients who were enrolled in the ED, and not patients enrolled in the inpatient setting.'}, {'type': 'PRIMARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '3% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': '0.9% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '2.87', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '2.86', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Length of stay defined as date of discharge minus date of admission (whole days)', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis for this outcome only includes patients who were admitted to inpatient status at the enrolling hospital and not transferred out.'}, {'type': 'PRIMARY', 'title': 'Change in RDAI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized 3% Saline', 'description': '3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.\n\nNebulized 3% saline: 4 ml inhaled q8h'}, {'id': 'OG001', 'title': 'Nebulized 0.9% Saline', 'description': '0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.\n\nNebulized 0.9% saline: normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '1.032', 'spread': '2.087', 'groupId': 'OG000'}, {'value': '0.8557', 'spread': '1.650', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Hour', 'description': 'The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes patients who did not receive any doses of study medication (17), patients missing pre-tx score (7), post-tx score (4), or both (1).'}, {'type': 'SECONDARY', 'title': 'Hours of Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized 3% Saline', 'description': '3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.\n\nNebulized 3% saline: 4 ml inhaled q8h'}, {'id': 'OG001', 'title': 'Nebulized 0.9% Saline', 'description': '0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.\n\nNebulized 0.9% saline: normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '32.88', 'spread': '39.99', 'groupId': 'OG000'}, {'value': '31.39', 'spread': '44.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Hours requiring supplemental oxygen for admitted patients.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes patients withdrawn by investigator due to ICU admission or ineligible condition (12), withdrawn by parent (6), and missing data (3)'}, {'type': 'SECONDARY', 'title': 'IV Fluid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized 3% Saline', 'description': '3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.\n\nNebulized 3% saline: 4 ml inhaled q8h'}, {'id': 'OG001', 'title': 'Nebulized 0.9% Saline', 'description': '0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.\n\nNebulized 0.9% saline: normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '51.38', 'spread': '90.15', 'groupId': 'OG000'}, {'value': '59.73', 'spread': '107.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'IV fluid volume administered during entire hospitalization, in mL/kg', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes patients withdrawn by investigator due to ICU admission or ineligible condition (12), withdrawn by parent (6), and missing data (3)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Supplemental Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized 3% Saline', 'description': '3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.\n\nNebulized 3% saline: 4 ml inhaled q8h'}, {'id': 'OG001', 'title': 'Nebulized 0.9% Saline', 'description': '0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.\n\nNebulized 0.9% saline: normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '230 patients were allocated to the 3% group; one patient allocated to the 0.9% group received 3% so was added to the 3% group for analysis, totaling 231 patients. The 0.9% group originally had 217 patients but after moving this patient to the 3% group, there are now 216 patients in the 0.9% group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypertonic Saline', 'description': '3% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge'}, {'id': 'FG001', 'title': 'Normal Saline', 'description': '0.9% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '217'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '195'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Transfer to outside facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Left before receiving first dose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'ICU admission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': "Subjects were recruited beginning March 2008 and April 2011, only during months of bronchiolitis season (November through April). Recruitment occurred in the emergency department and general medical inpatient units at 2 urban tertiary free-standing children's hospitals in the U.S.", 'preAssignmentDetails': 'No patients were excluded after enrollment but before randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypertonic Saline', 'description': '3% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge'}, {'id': 'BG001', 'title': 'Normal Saline', 'description': '0.9% NaCl, 4 ml, via updraft wall nebulizer:\n\n* In ED: every 20 minutes up to 3 doses\n* In Inpatient: every 8 hours until discharge'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.42', 'groupId': 'BG000'}, {'value': '0.53', 'spread': '0.43', 'groupId': 'BG001'}, {'value': '0.54', 'spread': '0.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-01', 'studyFirstSubmitDate': '2008-02-08', 'resultsFirstSubmitDate': '2013-07-29', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-29', 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admission Rate', 'timeFrame': '1 day', 'description': 'Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.'}, {'measure': 'Length of Stay', 'timeFrame': '1 month', 'description': 'Length of stay defined as date of discharge minus date of admission (whole days)'}, {'measure': 'Change in RDAI Score', 'timeFrame': '1 Hour', 'description': 'The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement.'}], 'secondaryOutcomes': [{'measure': 'Hours of Oxygen Use', 'timeFrame': '14 days', 'description': 'Hours requiring supplemental oxygen for admitted patients.'}, {'measure': 'IV Fluid Use', 'timeFrame': '14 days', 'description': 'IV fluid volume administered during entire hospitalization, in mL/kg'}, {'measure': 'Number of Participants With Supplemental Medication Use', 'timeFrame': '14 days', 'description': 'patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiolitis', 'hypertonic saline'], 'conditions': ['Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '24862623', 'type': 'DERIVED', 'citation': 'Wu S, Baker C, Lang ME, Schrager SM, Liley FF, Papa C, Mira V, Balkian A, Mason WH. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial. JAMA Pediatr. 2014 Jul;168(7):657-63. doi: 10.1001/jamapediatrics.2014.301.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.', 'detailedDescription': "Bronchiolitis is the most common viral respiratory infection in young children and infants. It is responsible for hundreds of thousands of outpatient visits and hospitalizations every year. Hypertonic saline may decrease swelling in the lung tissue, improve the patient's ability to clear secretions, and decrease nasal congestion. Hypertonic saline nebulizations have already been used effectively in patients with cystic fibrosis and in a few small trials on infants with bronchiolitis. Patients who come to the emergency department or inpatient ward of two urban free-standing pediatric hospitals in California between December and April and are diagnosed with bronchiolitis will be randomized into two groups- the control group will receive nebulized 0.9% normal saline, while the study group will receive nebulized 3% hypertonic saline. Nebulizations will be pretreated with albuterol, to prevent the theoretical risk of increased wheezing in patients with undiagnosed underlying asthma. Patients will be given up to 3 nebulizations in the emergency department, after which time the attending physician will decide whether admission to the hospital is required. Patients who are admitted will continue to receive the same nebulized treatment every 8 hours until discharged. Additional interventions such as epinephrine treatments and antibiotics can be ordered as indicated by the patient care team.\n\nInvestigators will measure symptom severity before and after treatments using the respiratory distress assessment instrument (RDAI). The investigators will compare rates of being admitted to the hospital in each group. The investigators will also compare RDAI scores, average length of stay, number of additional respiratory treatments needed, number of hours requiring oxygen, amount of IV fluid needed, and frequency of adverse effects. The investigators hypothesize that nebulized hypertonic saline will be a safe, cost-effective, and efficacious therapy which can be utilized in the outpatient setting to prevent hospital admission, as well as decrease length of stay for patients who require admission. Given the significant disease burden of viral bronchiolitis, the potential impact is substantial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of viral bronchiolitis\n* between November and April\n\nExclusion Criteria:\n\n* prematurity \\< 34 weeks\n* chronic lung disease\n* congenital heart disease\n* history of wheezing, asthma or albuterol use\n* tracheostomy status\n* need for intensive care of assisted ventilation'}, 'identificationModule': {'nctId': 'NCT00619918', 'briefTitle': 'Nebulized Hypertonic Saline for Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis', 'orgStudyIdInfo': {'id': 'CCI-06-00271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized 3% Saline', 'description': '3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.', 'interventionNames': ['Drug: Nebulized 3% saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nebulized 0.9% Saline', 'description': '0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.', 'interventionNames': ['Drug: Nebulized 0.9% saline']}], 'interventions': [{'name': 'Nebulized 3% saline', 'type': 'DRUG', 'otherNames': ['3% saline', 'Hypertonic saline', 'NaCl 3%'], 'description': '4 ml inhaled q8h', 'armGroupLabels': ['Nebulized 3% Saline']}, {'name': 'Nebulized 0.9% saline', 'type': 'DRUG', 'otherNames': ['Normal saline', 'NS', 'NaCl 0.9%'], 'description': 'normal saline', 'armGroupLabels': ['Nebulized 0.9% Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital & Research Center at Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Susan Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Childrens Hospital Los Angeles/University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'collaborators': [{'name': "UCSF Benioff Children's Hospital Oakland", 'class': 'OTHER'}, {'name': 'Thrasher Research Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Pediatrics', 'investigatorFullName': 'Susan Wu', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}