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IRCT20120415009475N9 IRCT 2021-05-30 Shahid Beheshti University of Medical Sciences Evaluation of Probiotic Efficacy in Prevention of Ventilator Associated Pneumonia Probiotic prophylaxis to prevent ventilator-associated pneumonia in children on mechanical ventilation: A randomized double-blind clinical trial 2021-05-22 anticipated 200 Complete https://irct.ir/trial/55996 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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 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. N/A Ventilator-associated Pneumonia. Intervention 1: Intervention group: In addition to routine interventions to prevent VAP, patients will receive the Lactobacillus rutri probiotic sachet twice daily. Intervention 2: Control group: In addition to receiving routine interventions, they will receive probiotic-free sachets. Yes - There is a plan to make this available What will be shared: The main outcome will be available. When: Six months after publishing. To whom: The data will be available per request for people working in academic institutions. Conditions: The data will available for using in systematic review and meta-analysis. Where to obtain: The data will be available by contacting email; mirrahimi@sbmu.ac.ir. How to obtain: The data will available for using in systematic review and meta-analysis. Comments:
public Soheil Roshanzamiri
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Niayesh junction, Valiasr Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2222 7029 Roshanzamirisoheil@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Bahador Mirrahimi
Mofid children's Hospital, Miradmad Junction, Shariaty Ave.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7020 mirrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 28 days to 12 years Children who were likely to require mechanical ventilation for more than 48 h 28 days 12 years Both Underlying immunodeficiency Paralytic ileus Gastrointestinal bleeding J95.851 Ventilator associated pneumonia Prevention Placebo Intervention group: In addition to routine interventions to prevent VAP, patients will receive the Lactobacillus rutri probiotic sachet twice daily. Control group: In addition to receiving routine interventions, they will receive probiotic-free sachets. Incidence of ventilator associated pneumonia. Timepoint: 14 days after intubation. Method of measurement: Chest x-ray, Clinical sign and Lab Data. Duration of ICU stay. Timepoint: Daily. Method of measurement: Day. Duration of Mechanical Ventilation. Timepoint: Daily. Method of measurement: Day. Shahid Beheshti University of Medical Sciences Approved 2021-03-07 institutional ethics committee for Pharmacy, Nursing and Midwifery Schools 2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction Tehran Tehran Iran (Islamic Republic of)