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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
  Purpose

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.


Condition
Bronchiolitis

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

Resource links provided by NLM:


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 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01238445

Contacts
Contact: Christopher L Carroll, MD, MS 860-545-9805 ccarrol@ccmckids.org

Locations
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Christopher L Carroll, MD, MS    860-545-9805    ccarrol@ccmckids.org   
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
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
ClinicalTrials.gov Identifier: NCT01238445     History of Changes
Other Study ID Numbers: 10-095
Study First Received: November 8, 2010
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
Pediatric

Additional relevant MeSH terms:
Bronchiolitis
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 20, 2014