Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04542005
Status:
WITHDRAWN
Last Update Posted:
2021-08-19
First Post:
2020-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding not obtained', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Treatment Days', 'timeFrame': 'Hospitalization to 15 days after discharge'}], 'secondaryOutcomes': [{'measure': 'Total Costs', 'timeFrame': 'Hospitalization to 15 days after discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['albuterol', 'asthma exacerbation'], 'conditions': ['Asthma in Children']}, 'descriptionModule': {'briefSummary': "Asthma is the most common chronic condition among children, and the third leading reason for hospitalization of children in the United States. It exerts a large healthcare burden on the US with estimated annual direct healthcare cost of approximately $50.1 billion with indirect costs of $5.9 billion.\n\nAsthma is characterized by airway inflammation and airway constriction. Albuterol and other betaagonists are first line standard of care for acute exacerbations and provide short acting smooth muscle relaxation and subsequent airway opening. The frequency of albuterol administration is dependent on the severity of the exacerbation. For hospitalized patients here at Children's Memorial Hermann (CMHH), patients may receive nebulized albuterol continuously or if the exacerbation is not as severe, receive albuterol intermittently. Intermittent albuterol frequency ranges from every two hour treatments, every three hour (q3h) treatments, or every four hour (q4h) treatments. As patients recover from their acute exacerbation, their frequency of albuterol administration is progressively titrated along this continuum. Expert consensus uses q4h albuterol as discharge criteria from the hospital. However, recent QI initiatives have studied the effect of q3h treatments as the discharge cutoff with no reported changes in safety or harm. There are no randomized controlled trials available. Furthermore, there are no economic evaluations available to see if costs saved by decreasing the length of hospital care are merely being shifted to subsequent clinic or emergency room care costs.\n\nThe investigators aim to conduct a randomized control trial to compare q3h vs. q4h albuterol as hospital discharge criteria for patients admitted for acute asthma exacerbations. The investigators also propose to conduct a costeffectiveness analysis of the trial. If the hypothesis that q3h albuterol is safe and as effective as q4h albuterol as discharge criteria, the investigators would be able to argue for a new standard of care that is more cost effective for this very costly and common disease of children in the United States"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with Primary Reason for Hospitalization of Asthma Exacerbation\n\nExclusion Criteria:\n\n* Those that never needed q3h albuterol treatments'}, 'identificationModule': {'nctId': 'NCT04542005', 'briefTitle': 'Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations', 'orgStudyIdInfo': {'id': 'HSC-MS-20-0604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'q3h albuterol', 'description': 'Using q3h as discharge criteria from hospital', 'interventionNames': ['Behavioral: q3h albuterol']}, {'type': 'NO_INTERVENTION', 'label': 'q4h albuterol', 'description': 'Using q4h as discharge criteria from hospital'}], 'interventions': [{'name': 'q3h albuterol', 'type': 'BEHAVIORAL', 'description': 'Using q3h albuterol as discharge criteria from hospital', 'armGroupLabels': ['q3h albuterol']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Raymond Parlar-Chun', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}