Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

Status Asthmaticus Clinical Trial

Official title:

Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124995
• Other study ID #: 05-001
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2005
• Last updated: February 12, 2013
• Start date: October 2003
• Est. completion date: October 2006

Study information

• Verified date: February 2013
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Status Asthmaticus

Intervention

Drug:
• terbutaline

Locations

Country	Name	City	State
United States	CT Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU length of stay
Secondary	To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
Secondary	To prospectively analyze the side effects of terbutaline