Health Condition 1: null- Sepsis
Conditions
Interventions
Intervention1: Probiotic: The probiotic preparation is formulated in packets as a granulated powder (20 mesh). The formulation used will contain a total of 450 billion bacteria. Each packet contains
Sponsors
ICMR Applied for
Eligibility
Inclusion criteria
Inclusion criteria: a)Children in the age range 3 months to 12 years who are admitted in pediatric intensive care unit b)Children with a diagnosis of severe sepsis as defined by ACCM/SCCM guidelines and needing broad spectrum antibiotics > 48 hours c)Informed consent from parents
Exclusion criteria
Exclusion criteria: a)Antibiotic received for > 48 hrs prior to enrolment b)Known immunodeficiency c)On immunosuppressive therapy for > 7 days d)Probiotic treatment in last 7 days e)Previous enrolment in study f)Prior hospitalization for > 48 hours in last 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i) To evaluate whether probiotic added as an adjunct to antibiotic treatment reduces the duration of IV antibiotic therapy in children with severe sepsis.Timepoint: reduction in duration of antibiotic therapy by â?¥ 20% in children with severe sepsis who receive probiotic as an adjunct as compared to children who receive placebo. This will be measured at 7 days, 14 days and at discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Role of probiotic as an adjunct therapy on in-PICU mortality. Compare incidence of secondary/nosocomial infection in the both groups. Compare improvement in laboratory markers of sepsis in the both groups at 72 hours, day 5 & 7 post enrollment. Compare Sequential Organ Failure Score in both groups from day 0 onwards till discharge. Adverse events of probiotics in critically ill childrenTimepoint: At day 3, 5, 7 and at discharge | — |
Countries
India
Contacts
Public ContactArun Bansal
PGIMER
Outcome results
None listed