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Assessing Response to Albuterol in Bronchiolitis

This study has been completed.
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: January 31, 2017
Last verified: January 2017
  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 Christopher Carroll, MD, Connecticut Children's Medical Center:

Primary Outcome Measures:
  • Our primary outcome is the response to albuterol. [ Time Frame: 20 minutes following an albuterol treatment ]

Enrollment: 29
Study Start Date: November 2010
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Detailed Description:
We propose to conduct a prospective observational study of healthcare providers to determine the accuracy of clinical assessment as compared to the assessment of pulmonary mechanics in a population of children intubated and mechanically ventilated for bronchiolitis. Before and at 20 minutes following a routinely scheduled albuterol treatment, measurements of pulmonary mechanics obtained as part of the child's clinical care will be compared to a healthcare provider's simultaneous clinical assessment. Three healthcare providers (a nurse, physician, and respiratory therapist) will assess the child during these time periods. Data regarding their observations will be recorded using a data collection tool (attached). Healthcare providers will be blinded to each other's assessments and to the measurements of pulmonary mechanics. Using sensitivity and specificity analysis, the healthcare provider's assessment of response will be compared to the standard assessment of response according to the measurements of pulmonary mechanics. A precision of the estimate of sensitivity and specificity will be calculated. Clinical characteristics of the child will be recorded. Each child may be assessed on up to three occasions if that child receives greater than 1 dose of albuterol. However, no more than 3 providers will assess the child at one time.
  Eligibility

Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
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

Locations
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: Christopher L Carroll, MD, MS Connecticut Children's Medical Center
  More Information

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: January 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Carroll, MD, Connecticut Children's Medical Center:
Pediatric

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017