Assessing Response to Albuterol in Bronchiolitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Connecticut Children's Medical Center
Sponsor:
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT01238445
First received: November 8, 2010
Last updated: February 12, 2013
Last verified: February 2013

November 8, 2010
February 12, 2013
November 2010
April 2015   (final data collection date for primary outcome measure)
Our primary outcome is the response to albuterol. [ Time Frame: 20 minutes following an albuterol treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01238445 on ClinicalTrials.gov Archive Site
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Assessing Response to Albuterol in Bronchiolitis
Assessing Response to Albuterol in Bronchiolitis

Bronchiolitis is a significant cause of morbidity and hospitalizations in children, accounting for more than 125,000 hospitalized children per year in the United States. Although treatment is largely supportive, bronchodilator medications such as albuterol are frequently used due to increased pulmonary resistance in this population.2-4 However, despite four decades of clinical trials, the efficacy of albuterol in the treatment of bronchiolitis has yet to be proven. This inconsistency is due in part to the lack of sufficiently sensitive methods for the evaluation of lung function and thus the response to albuterol in infants. Because of the difficulties in evaluating the response to therapy, healthcare providers are forced to rely on their physical examination skills or a clinical scoring system, both of which are highly subjective in this population. The investigators propose to conduct a prospective observational study of healthcare providers to determine the accuracy of clinical assessment as compared to that of pulmonary mechanics in a population of children intubated and mechanically ventilated for bronchiolitis.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Children hospitalized in the intensive care unit with bronchiolitis

Bronchiolitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalization with a primary admission diagnosis of bronchiolitis
  • Age between birth and 2 years
  • Intubated with < 1 cm H2O leak around endotracheal tube
  • Receiving inhaled albuterol therapy

Exclusion Criteria:

- Not meeting inclusion criteria

Both
up to 2 Years
No
Contact: Christopher L Carroll, MD, MS 860-545-9805 ccarrol@ccmckids.org
United States
 
NCT01238445
10-095
No
Christopher Carroll, MD, Connecticut Children's Medical Center
Connecticut Children's Medical Center
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Principal Investigator: Christopher L Carroll, MD, MS Connecticut Children's Medical Center
Connecticut Children's Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP