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IRCT20220912055944N1 IRCT 2023-05-04 Esfahan University of Medical Sciences Study of the effect of symbiotics on preventing ventilator- associated pneumonia Study of the effect of symbiotics on preventing ventilator- associated pneumonia in children on mechanical ventilation 2023-05-10 anticipated 70 Complete https://irct.ir/trial/68714 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Other design features: In this study, the intervention group receives the drug and the control group receives nothing. 3 Condition 1: Ventilator-associated pneumonia. Condition 2: Duration of mechanical ventilation. Condition 3: Duration of ICU stay. Condition 4: Duration of hospital stay. Condition 5: Mortality rate. Intervention 1: Intervention group: The patients who were put in this group prescribed KidiLact during the first 24 hour after intubation. This drug is produced by Zisttakhmir company and it includes synbiotic (peribiotic + probiotic) suitable for children up to 10 years old. It contains 10 safe and useful bacteria including the especial kind of bacteria for children called bifidobacterium infantis and fructooligosaccaride as a peribiotic. KidiLact is sold as a sachet as it can be used easily for children. It includes Lactobacilus ramnosus, Lactobacilus roteri, Lactobacilus acidophilus, Lactibacilus bulgaris, Lactobacilus kazei, Bifidobacterium infantis, Bifidobacterium berveh, Bifidobacterium bifidum, Bifidobacterium lactis, Streptococcus termophilus with the colony count of 109 and fructooligosaccaride as a peribiotic. The patients were received one sachet orally twice a day for seven days. Intervention 2: Control group: The patients in this group were received nothing after mechanical ventilation. Yes - There is a plan to make this available What will be shared: Study of the effect of symbiotics on preventing ventilator-associated pneumonia in children on mechanical ventilation When: From the publication date of the article To whom: The researchers of the universities and research centers Conditions: Citation of the published paper Where to obtain: Hanieh Basirkazeruni: 00989131009655- hany_med1384@yahoo.com Sharareh Babai: 00989133190061- sharareh.ba@gmail.com How to obtain: Sending an email to the corresponding author of the paper Comments:
public Hanieh Basirkazeruni
App. 2, Amir building, No. 14, Amininezhad St., Northern sheikh sadough Ave.
Isfahan Iran (Islamic Republic of) 8163614143 +98 31 3666 4034 hany_med1384@yahoo.com Esfahan University of Medical Sciences scientific Sharareh Babai
Imam hosein children's hospital, Imam khomeini Ave.,
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 sharareh.ba@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children supported by mechanical ventilation for at least 48 hours and without primary immunodeficiency 1 month 9 years Both Primary immunodeficiency J20-J22 Other acute lower respiratory infections Prevention Prevention Intervention group: The patients who were put in this group prescribed KidiLact during the first 24 hour after intubation. This drug is produced by Zisttakhmir company and it includes synbiotic (peribiotic + probiotic) suitable for children up to 10 years old. It contains 10 safe and useful bacteria including the especial kind of bacteria for children called bifidobacterium infantis and fructooligosaccaride as a peribiotic. KidiLact is sold as a sachet as it can be used easily for children. It includes Lactobacilus ramnosus, Lactobacilus roteri, Lactobacilus acidophilus, Lactibacilus bulgaris, Lactobacilus kazei, Bifidobacterium infantis, Bifidobacterium berveh, Bifidobacterium bifidum, Bifidobacterium lactis, Streptococcus termophilus with the colony count of 109 and fructooligosaccaride as a peribiotic. The patients were received one sachet orally twice a day for seven days. Control group: The patients in this group were received nothing after mechanical ventilation. Percentage of patients who were infected with ventilator-associated pneumonia. Timepoint: At the beginning, middle and the end of the study. Method of measurement: Nonbronchoscopic bronchoalveolar lavage (NB-BAL). Duration of ventilator-associated pneumonia treatment. Timepoint: Beginning and end of the treatment. Method of measurement: Number of the days that ventilator-associated pneumonia was treated. Duration of mechanical ventilation. Timepoint: Beginning and end of the mechanical ventilation. Method of measurement: Number of the days the patients were under mechanical ventilation. Duration of hospitalization in pediatric intensive care unit. Timepoint: Beginning and end of the hospitalization in pediatric intensive care unit. Method of measurement: Number of the days the patients were hospitalized in pediatric intensive care unit. Duration of hospitalization. Timepoint: Beginning and end of the hospitalization. Method of measurement: Number of the days the patients were hospitalized. Mortality rate. Timepoint: End of the study. Method of measurement: Counting the deaths. Esfahan University of Medical Sciences Approved 2022-06-27 Ethics committee of Isfahan University of Medical Sciences Esfahan University of Medical Sciences, Hezar Jarib Ave. Esfahan Isfehan Iran (Islamic Republic of)