Assessing Response to Albuterol in Bronchiolitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Connecticut Children's Medical Center
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center Identifier:
First received: November 8, 2010
Last updated: February 3, 2015
Last verified: February 2015

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.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessing Response to Albuterol in Bronchiolitis

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • Our primary outcome is the response to albuterol. [ Time Frame: 20 minutes following an albuterol treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: November 2010
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children hospitalized in the intensive care unit with bronchiolitis


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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01238445

Contact: Christopher L Carroll, MD, MS 860-545-9805

United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Christopher L Carroll, MD, MS    860-545-9805   
Sponsors and Collaborators
Connecticut Children's Medical Center
Principal Investigator: Christopher L Carroll, MD, MS Connecticut Children's Medical Center
  More Information

No publications provided

Responsible Party: Christopher Carroll, MD, Associate Professor of Pediatrics, Connecticut Children's Medical Center Identifier: NCT01238445     History of Changes
Other Study ID Numbers: 10-095
Study First Received: November 8, 2010
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:

Additional relevant MeSH terms:
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on October 08, 2015