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Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

Primary Purpose

Status Asthmaticus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
terbutaline
Sponsored by
Connecticut Children's Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Asthmaticus

Eligibility Criteria

undefined - 18 Years (Child, Adult)All Sexes

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

Sites / Locations

  • CT Children's Medical Center

Outcomes

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

Full Information

First Posted
July 27, 2005
Last Updated
February 12, 2013
Sponsor
Connecticut Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00124995
Brief Title
Trial of Terbutaline for the Treatment of Status Asthmaticus in Children
Official Title
Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Connecticut Children's Medical Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Asthmaticus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
terbutaline
Primary Outcome Measure Information:
Title
ICU length of stay
Secondary Outcome Measure Information:
Title
To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
Title
To prospectively analyze the side effects of terbutaline

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Carroll, MD
Organizational Affiliation
CT Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CT Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

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