Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

Phase 4

Completed

• Conditions: Status Asthmaticus

• Registration Number: NCT00124995
• Lead Sponsor: Connecticut Children's Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-07-27
• Study First Submitted QC: 2005-07-27
• Study First Posted: 2005-07-29
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ICU length of stay

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
To prospectively analyze the side effects of terbutaline

Trial Locations

Locations (1)

CT Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States