Trial of Terbutaline for the Treatment of Status Asthmaticus in Children
Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2003
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 27, 2005
CompletedFirst Posted
Study publicly available on registry
July 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFebruary 15, 2013
February 1, 2013
3 years
July 27, 2005
February 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
ICU length of stay
Secondary Outcomes (2)
To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
To prospectively analyze the side effects of terbutaline
Interventions
Eligibility Criteria
You may qualify if:
- Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus
- Modified Pulmonary Index Score (MPIS) of greater than or equal to 12
- Age between birth and 18 years old
You may not qualify if:
- Pre-existing cardiac or pulmonary disease
- Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation)
- Hemodynamic or cardiovascular instability requiring inotropic support
- The patient meets one of the criteria for withdrawal from the study due to patient safety concerns
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CT Children's Medical Center
Hartford, Connecticut, 06106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Carroll, MD
CT Children's Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
July 27, 2005
First Posted
July 29, 2005
Study Start
October 1, 2003
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
February 15, 2013
Record last verified: 2013-02