Assessing Response to Albuterol in Bronchiolitis
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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 |
- 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 |
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| Contact: Christopher L Carroll, MD, MS | 860-545-9805 | ccarrol@ccmckids.org |
| 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 | |
| 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 Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Albuterol Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 17, 2013