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Completed

NCT Number: NCT00124995

Trial of Terbutaline for 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.

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Key information

Conditions

Status Asthmaticus Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CT Children's Medical Center

Hartford, Connecticut, 06106, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terbutaline

Drug

Primary outcomes

  1. ICU length of stay

Secondary outcomes

  1. To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission

  2. To prospectively analyze the side effects of terbutaline

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Official study title

Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jul 29, 2005
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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