Glucocorticoid Therapy Impact on the Inflammatory Response and Clinical Evolution in Patients With Severe Bronchiolitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02571517|
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : October 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis, Viral||Drug: Glucocorticoids Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
methylprednisolone intravenous administration of 2mg/kg/day (divided in two doses) and/or oral prednisolone 2,5 mg/kg/day (in two divided doses) during 7 days.
Patients younger than 2 year, who required hospitalization, affected by moderate or severe bronchiolitis
Patients assigned to experimental group (group 1) will receive iv methylprednisolone 2 mg/kg/day (divided in two doses) doses and/or oral prednisolone 2,5 mg/kg/day (divided in two doses) during 7 days.
Placebo Comparator: Placebo
will receive iv/oral glucose 5% solution as placebo of 2mg/kg/day and/or 2,5 mg/kg/day (divided in two doses) during 7 days.
Patients younger than 2 year, who required hospitalization, affected by moderate or severe bronchiolitis.
Patients assigned to control group (group 2) will receive iv/oral glucose 5% solution as placebo, 2 mg/kg/day (divided in two doses) during 7 days.
- Change from Baseline in inflammatory response [ Time Frame: enrollment to one week treatment ]inflammatory response evaluation of the first week of glucocorticoids treatment as assessed by multiple measurements aggregated to arrive at one reported value, which are: the bronchiolitis clinical severity Scale, pediatric mortality Risk scale (PRISM III), the Chest x-ray test, the nasopharyngeal aspiration and analytical exploration (at day 5-7)
- Morbidity episodes [ Time Frame: 14 months ]Morbidity assessment by multiple measurements aggregated to arrive at one reported value which are as follow: necessity of mechanical ventilation, inotropic, presence of nosocomial infection, rescue therapies if respiratory failure occur; days of admission to the Pediatric Intensive Care Unit and hospitalization, in both treatment and control groups
- Number of Side effects estimate [ Time Frame: 14 months ]Number of Side effects estimate by comparing the experimental group to the control group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571517
|Principal Investigator:||Iolanda Jordán, MD||UCIP H Sant Joan de Déu|