Assessing Response to Albuterol in Bronchiolitis
| Tracking Information | |||||
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| First Received Date ICMJE | November 8, 2010 | ||||
| Last Updated Date | February 12, 2013 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Our primary outcome is the response to albuterol. [ Time Frame: 20 minutes following an albuterol treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01238445 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessing Response to Albuterol in Bronchiolitis | ||||
| Official Title ICMJE | Assessing Response to Albuterol in Bronchiolitis | ||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Children hospitalized in the intensive care unit with bronchiolitis |
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| Condition ICMJE | Bronchiolitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 25 | ||||
| Estimated Completion Date | April 2015 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Not meeting inclusion criteria |
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| Gender | Both | ||||
| Ages | up to 2 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01238445 | ||||
| Other Study ID Numbers ICMJE | 10-095 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christopher Carroll, MD, Connecticut Children's Medical Center | ||||
| Study Sponsor ICMJE | Connecticut Children's Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Connecticut Children's Medical Center | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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