Protocol summary
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Study aim
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Investigate the incidence of ventilator associated pneumonia in children on mechanical ventilation
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Design
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A randomized blinded placebo-controlled trial on 200 pediatric patients on mechanical ventilation
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Settings and conduct
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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 (PIM-3) score, will be recorded for all patients and evaluated in case of VAP.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Incidence of ventilator associated pneumonia (VAP)
General information
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Reason for update
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The manuscript of this RCT was accepted.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120415009475N9
Registration date:
2021-05-30, 1400/03/09
Registration timing:
registered_while_recruiting
Last update:
2022-11-04, 1401/08/13
Update count:
1
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Registration date
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2021-05-30, 1400/03/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-22, 1400/03/01
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Expected recruitment end date
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2022-05-22, 1401/03/01
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Actual recruitment start date
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2021-05-22, 1400/03/01
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Actual recruitment end date
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2022-07-09, 1401/04/18
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Trial completion date
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2022-07-23, 1401/05/01
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Scientific title
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Probiotic prophylaxis to prevent ventilator-associated pneumonia in children on mechanical ventilation: A randomized double-blind clinical trial
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Public title
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Evaluation of Probiotic Efficacy in Prevention of Ventilator Associated Pneumonia
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 28 days old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
200
Actual sample size reached:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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/.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-07, 1399/12/17
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1399.383
Health conditions studied
1
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Description of health condition studied
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Ventilator-associated Pneumonia
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ICD-10 code
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J95.851
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ICD-10 code description
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Ventilator associated pneumonia
Primary outcomes
1
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Description
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Incidence of ventilator associated pneumonia
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Timepoint
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14 days after intubation
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Method of measurement
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Chest x-ray, Clinical sign and Lab Data
Secondary outcomes
1
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Description
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Duration of ICU stay
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Timepoint
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Daily
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Method of measurement
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Day
2
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Description
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Duration of Mechanical Ventilation
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Timepoint
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Daily
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Method of measurement
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Day
Intervention groups
1
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Description
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Intervention group: In addition to routine interventions to prevent VAP, patients will receive the Lactobacillus rutri probiotic sachet twice daily.
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Category
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Prevention
2
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Description
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Control group: In addition to receiving routine interventions, they will receive probiotic-free sachets.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The main outcome will be available.
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When the data will become available and for how long
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Six months after publishing.
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To whom data/document is available
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The data will be available per request for people working in academic institutions.
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Under which criteria data/document could be used
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The data will available for using in systematic review and meta-analysis.
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From where data/document is obtainable
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The data will be available by contacting email; mirrahimi@sbmu.ac.ir.
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What processes are involved for a request to access data/document
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The data will available for using in systematic review and meta-analysis.
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Comments
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