A RANDOMIZED CONTROLLED TRIAL TO STUDY THE EFFECT OF PROBIOTICS ON CHANGE IN LEVELS OF INFLAMMATORY MEDIATORS IN CRITICALLY ILL CHILDREN WITH SEVERE SEPSIS.
Not Applicable
- Conditions
- Health Condition 1: null- CRITICALLY ILL CHILDREN WITH SEVERE SEPSIS
- Registration Number
- CTRI/2015/04/005708
- Lead Sponsor
- POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Any patient admitted to PICU with diagnosis of severe sepsis.
2. Age group: 3 months-12 years.
Exclusion Criteria
1. Hospital stay of >72 hours prior to PICU admission.
2. Children who cannot tolerate enteral nutrition.
3. Known chronic illness.
4. Suspected or proven viral infection.
5. Known immunodeficiency states or malignancy.
6. Children on prior steroids/immunotherapy.
7. Children with severe acute malnutrition (as per WHO).
8. Children who received probiotic therapy in last 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in levels of cytokines (IL-6, IL-12, IL-17, TNF- α, IL-10, and TGF-β) in critically ill children with severe sepsis receiving probiotics and those receiving placeboTimepoint: Day 1 and day 7
- Secondary Outcome Measures
Name Time Method To compare the two groups for: <br/ ><br>â?¢SOFA score on day 1 and 7 <br/ ><br>â?¢Incidence of health care associated infection (HCAI) <br/ ><br>â?¢Length of PICU stay <br/ ><br>â?¢Survival or death <br/ ><br>Timepoint: Patients will be followed up till the discharge from PICU or death.