A clinical trial to compare the effects of two methods of oxygen delivery system in children with severe pneumonia requiring oxygen treatment
Not Applicable
Completed
- Conditions
- Health Condition 1: null- PneumoniaHealth Condition 2: J189- Pneumonia, unspecified organism
- Registration Number
- CTRI/2016/04/006788
- Lead Sponsor
- INCLEN Trust International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 244
Inclusion Criteria
All consecutive children aged 2months to 5 years admitted to pediatric emergency room with severe pneumonia requiring oxygen therapy would be enrolled in this study after getting informed consent from parents
Exclusion Criteria
•Children diagnosed to have chronic lung disease
•Any child hospitalized for respiratory illness in last one month period
•Children previously diagnosed to have bronchial asthma
•Children receiving home mechanical ventilation
•Children diagnosed to have preexisting neuromuscular disease
•Congenital cardiac malformations or other multiple malformations
•Children diagnosed to have empyema at admission to emergency room
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â??Treatment Failureâ?? in 72 hours of hospitalization would be the primary outcome measure and â??Treatment failure could include any of following (i) Endotracheal intubation, (ii) Mechanical ventilation, (iii) escalating the respiratory support method (using any modality other than primary intervention method)Timepoint: â??Treatment Failureâ?? in 72 hours of hospitalization would be the primary outcome measure and â??Treatment failure could include any of following (i) Endotracheal intubation, (ii) Mechanical ventilation, (iii) escalating the respiratory support method (using any modality other than primary intervention method)
- Secondary Outcome Measures
Name Time Method a.Time to clinical stability in hours [Continuous variable] <br/ ><br>b.Time to respiratory stability in hours [Continuous variable] <br/ ><br>c.Fluid balance (ml/kg) at 24 and 48 hours of hospitalization [continuous variable] <br/ ><br>d.Volume of crystalloid bolus requirement [Continuous variable] <br/ ><br>e.Mortality (In hospital and in 30 days of discharge) [categorical variable] <br/ ><br>Timepoint: as specified