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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00124995
Other study ID # 05-001
Secondary ID
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
Accepts healthy volunteers
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


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
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