Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-01 @ 10:55 AM
Study NCT ID:
NCT00124995
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2005-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Terbutaline for the Treatment of Status Asthmaticus in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013224', 'term': 'Status Asthmaticus'}], 'ancestors': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013726', 'term': 'Terbutaline'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2005-07-27', 'studyFirstSubmitQcDate': '2005-07-27', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU length of stay'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission'}, {'measure': 'To prospectively analyze the side effects of terbutaline'}]}, 'conditionsModule': {'conditions': ['Status Asthmaticus']}, 'descriptionModule': {'briefSummary': 'Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus\n* Modified Pulmonary Index Score (MPIS) of greater than or equal to 12\n* Age between birth and 18 years old\n\nExclusion Criteria:\n\n* Pre-existing cardiac or pulmonary disease\n* Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation)\n* Hemodynamic or cardiovascular instability requiring inotropic support\n* The patient meets one of the criteria for withdrawal from the study due to patient safety concerns"}, 'identificationModule': {'nctId': 'NCT00124995', 'briefTitle': 'Trial of Terbutaline for the Treatment of Status Asthmaticus in Children', 'organization': {'class': 'OTHER', 'fullName': "Connecticut Children's Medical Center"}, 'officialTitle': 'Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children', 'orgStudyIdInfo': {'id': '05-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'terbutaline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "CT Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Christopher Carroll, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CT Children's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Christopher Carroll, MD', 'investigatorAffiliation': "Connecticut Children's Medical Center"}}}}