To see the effect of corticosteroids along with standard treatment in Pneumonia
Phase 3
Completed
- Conditions
- Health Condition 1: J159- Unspecified bacterial pneumonia
- Registration Number
- CTRI/2021/09/036799
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 132
Inclusion Criteria
All cases severe pneumonia will be diagnosed by following criteria:
i) 2 months to 59 months: WHO criteria for severe pneumonia will be used.
ii) 5 to 15 years: Child need to have tachypnea RR >20/min, fever >38 C, SPo2 <94% and radiological changes in CXR to include as severe pneumonia in our study.
Exclusion Criteria
1.Prior treatment with corticosteroids in past 3 months
2.Immunological deficiencies state
3.Prexisting liver, kidney or cardiac disease
4.Nosocomial pneumonia
5.Brochiolitis, bronchial asthma, empyema thoracics, persistent or recurrent pneumonia
6.Hemodynamically instability
7.Severe acute malnutrition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the effect of dexamethasone therapy to reduce the clinical failure in children aged 2 month to 15 years with severe community acquired pneumonia.Timepoint: Clinical failure in first 72 hours
- Secondary Outcome Measures
Name Time Method Secondary1.To compare the <br/ ><br>a. mortality, <br/ ><br>b. the duration of the hospital stays, <br/ ><br>c. need for mechanical ventilation, <br/ ><br>d. readmission rate within one month <br/ ><br>e. complications of pneumonia between two groups. <br/ ><br>2.To assess the severity of inflammation by assessing (ESR, hsCRP, IL-6,Il 8,IL 10,Procalcitonin) at time of admission and day 4 (after the stopping the steroid therapy) or at the time of discharge. <br/ ><br>Timepoint: To see the inflammatory markers before starting the intervention or placebo and after 72 hours or at time of discharge