Investigate the incidence of ventilator associated pneumonia in children on mechanical ventilation
Design
A randomized blinded placebo-controlled trial on 200 pediatric patients on mechanical ventilation
Settings and conduct
The randomization has been performed using the permuted block randomization table. The medication and placebo will be in look-alike coded packages. The codes based on the permuted block randomization table will be provided to the researcher by a designated person via phone.
The study is conducted on 200 pediatric patients admitted to Mofid children hospital pediatric intensive care unit (PICU) under mechanical ventilation. All children entering the PICU are monitored and enrolled if they meet the inclusion criteria. Intervention group: In addition to routine interventions to prevent ventilator-associated pneumonia (VAP), patients will receive the probiotic sachet twice daily, and in the control group, in addition to receiving common interventions, they will receive probiotic-free sachets. Patients will be monitoring for VAP daily. Patients' demographic information, including age, sex, indication for mechanical ventilation and the pediatric risk of mortality (PRISM) score, will be recorded for all patients and evaluated in case of VAP.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: age between 28 days to 12 years, children who were likely to require mechanical ventilation for more than 48 h; Exclusion Criteria: underlying immunodeficiency, paralytic ileus, gastrointestinal bleeding
Intervention groups
Intervention group: In addition to routine interventions to prevent VAP, patients will receive the Lactobacillus rutri probiotic sachet twice daily, and in the control group, in addition to receiving routine interventions, they will receive probiotic-free sachets.
Main outcome variables
Incidence of ventilator associated pneumonia (VAP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009475N9
Registration date:2021-05-30, 1400/03/09
Registration timing:registered_while_recruiting
Last update:2021-05-30, 1400/03/09
Update count:1
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Blinded Placebo-controlled Trial of Probiotic Prophylaxis to Prevent Ventilator Associated Pneumonia in Children on Mechanical Ventilation
Public title
Evaluation of Probiotic Efficacy in Prevention of Ventilator Associated Pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 28 days to 12 years
Children who were likely to require mechanical ventilation for more than 48 h
The randomization has been performed using the permuted block randomization table. The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. In our study, subjects will be randomized in 4 patient blocks. Randomization was centralized and computerized with a concealed randomization sequence carried out at https://www.sealedenvelope.com/.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medication and placebo will be in look-alike coded packages, and the codes based on the permuted block randomization table will be provided to the researcher by a designated person via phone. At the end of the study, after organizing the data by the same person, the statistical expert will perform the analysis. Then, the code packet will be opened, and the final results will be reported.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
institutional ethics committee for Pharmacy, Nursing and Midwifery Schools
Street address
2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2021-03-07, 1399/12/17
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.383
Health conditions studied
1
Description of health condition studied
Ventilator-associated Pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Incidence of ventilator associated pneumonia
Timepoint
14 days after intubation
Method of measurement
Chest x-ray, Clinical sign and Lab Data
Secondary outcomes
1
Description
Duration of ICU stay
Timepoint
Daily
Method of measurement
Day
2
Description
Duration of Mechanical Ventilation
Timepoint
Daily
Method of measurement
Day
Intervention groups
1
Description
Intervention group: In addition to routine interventions to prevent VAP, patients will receive the Lactobacillus rutri probiotic sachet twice daily.
Category
Prevention
2
Description
Control group: In addition to receiving routine interventions, they will receive probiotic-free sachets.