Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

This study has been completed.

First Received on July 27, 2005. Last Updated on September 7, 2006 History of Changes

Sponsor:	Connecticut Children's Medical Center
Information provided by:	Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:	NCT00124995

Purpose

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 IV

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:

MedlinePlus related topics: Asthma

Drug Information available for: Terbutaline Terbutaline sulfate

U.S. FDA Resources

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

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124995

Locations

United States, Connecticut
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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00124995 History of Changes
Other Study ID Numbers:	05-001
Study First Received:	July 27, 2005
Last Updated:	September 7, 2006
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Terbutaline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012