Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

• Sponsor: Connecticut Children's Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00124995
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Status Asthmaticus	Drug: terbutaline	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. ICU length of stay []

Secondary Outcome Measures

1. To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission []

2. To prospectively analyze the side effects of terbutaline []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CT Children's Medical Center	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

• Connecticut Children's Medical Center

Investigators

• Principal Investigator: Christopher Carroll, MD, CT Children's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher Carroll, MD, Associate Professor of Pediatrics, Connecticut Children's Medical Center
• ClinicalTrials.gov Identifier: NCT00124995
• Other Study ID Numbers: 05-001
• First Posted: Jul 29, 2005
• Last Update Posted: Feb 15, 2013
• Last Verified: Feb 1, 2013

• Additional relevant MeSH terms: Status Asthmaticus; Terbutaline

Study Results

No Results Posted as of Feb 15, 2013