Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

This study has been completed.
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center Identifier:
First received: July 27, 2005
Last updated: February 12, 2013
Last verified: February 2013
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 Intervention Phase
Status Asthmaticus
Drug: terbutaline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • ICU length of stay

Secondary Outcome Measures:
  • To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
  • To prospectively analyze the side effects of terbutaline

Estimated Enrollment: 40
Study Start Date: October 2003
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both

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
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Please refer to this study by its identifier: NCT00124995

United States, Connecticut
CT Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Principal Investigator: Christopher Carroll, MD CT Children's Medical Center
  More Information

Responsible Party: Christopher Carroll, MD, Associate Professor of Pediatrics, Connecticut Children's Medical Center Identifier: NCT00124995     History of Changes
Other Study ID Numbers: 05-001 
Study First Received: July 27, 2005
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Status Asthmaticus
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Tocolytic Agents processed this record on May 23, 2016