Steroid Therapy in Acute Bronchiolitis A New Old Line of Therapy.
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|ClinicalTrials.gov Identifier: NCT03436225|
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
Marina shohdy dous, Assiut University
The aim of the present study is to evaluate the efficacy of steroid therapy and hospital stay in patients with acute bronchiolitis at assiut university children hospital.
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis; Respiratory Syncytial Virus||Drug: Dexamethasone orally. Drug: Dexamethasone parenteral. Drug: Inhaled nebulized Budesonide. Drug: Inhaled nebulized salbutamol.||Phase 1|
Show detailed description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Steroid Therapy in Acute Bronchiolitis A New Old Line of Therapy.|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||March 2019|
Group one will receive dexamethasone orally (0.15mg /kg / dose) twice daily for 3 to 5 days.
Drug: Dexamethasone orally.
Administered orally (0.15mg /kg / dose) twice daily for 3 to 5 days.
Group two will receive dexamethasone parenteral (0.15mg /kg /dose) twice daily for 3 to 5 days.
Drug: Dexamethasone parenteral.
Administered parenteral (0.15mg /kg / dose) twice daily for 3 to 5 days.
Other Name: Fortecortin 8 mg /2 ml ampoule i.v /i.m injection .
Group three will receive inhaled nebulized budesonide (1 mg/2ml) twice daily for 3 to 5 days.
Drug: Inhaled nebulized Budesonide.
Administered for inhalation (1 mg/ 2ml) twice daily for 3 to 5 days.
Other Name: Pulmicorte respules1 mg /2 ml.
Group four will receive symptomatic treatment in form of inhaled nebulized salbutamol(0.15mg/kg/ dose) daily every 6-8 hours.
Drug: Inhaled nebulized salbutamol.
Administered for inhalation (0.15mg /kg / dose) daily every 6-8hrs
Other Name: Farcoline respirator 0,5% solution.
Primary Outcome Measures :
- Resolution of respiratory distress. [ Time Frame: <7 days ]A total clinical score ≤ 3 and oxygen saturation ≥ 95 % at room air together with respiratory score of 0 or 1, a wheezing score of 0 or 1, and a retraction muscle score of 0 or 1
Secondary Outcome Measures :
- Reduction of mean duration of symptoms. [ Time Frame: <7 days ]Improvement of respiratory symptoms within fewer days .
- Reduction of duration of oxygen therapy. [ Time Frame: <7 days ]Reduction the need for more oxygen therapy .
- Reduction of average Length of hospital stay. [ Time Frame: <7 days ]Decrease Length of hospital stay.
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