Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00124995
First received: July 27, 2005
Last updated: February 12, 2013
Last verified: February 2013

July 27, 2005
February 12, 2013
October 2003
October 2006   (final data collection date for primary outcome measure)
ICU length of stay
Same as current
Complete list of historical versions of study NCT00124995 on ClinicalTrials.gov Archive Site
  • To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
  • To prospectively analyze the side effects of terbutaline
  • - To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
  • - To prospectively analyze the side effects of terbutaline
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Status Asthmaticus
Drug: terbutaline
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00124995
05-001
Not Provided
Christopher Carroll, MD, Connecticut Children's Medical Center
Connecticut Children's Medical Center
Not Provided
Principal Investigator: Christopher Carroll, MD CT Children's Medical Center
Connecticut Children's Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP