The study of the effect of synbiotics on prevention of VAP in children on mechanical ventilation
Design
This clinical trial has control group without blinding, phase 3 on 35 patients in sample group and 35 patients on control group with non-random sampling method with the use of national code. Children with even national code are put in patient group and children with odd national code are put in control group.
Settings and conduct
This study is done at PICU in Imam Hossein Children's Hospital, Isfahan, Iran. After choosing the patient group, KidiLact is orally prescribed twice a day during seven days.
Participants/Inclusion and exclusion criteria
The studied population are the children aged from 1 month old to 9 years old who are on mechanical ventilation in PICU.
Inclusion criteria is the children who needs mechanical ventilation for more than 48 hours and without primary immunodeficiency. Non-inclusion criteria is children with primary immunodeficiency.
Intervention groups
The patient group are children on mechanical ventilation who are prescribed synbiotics and the control group are the children on mechanical ventilation who receives nothing.
Main outcome variables
Reduction of VAP; reduction of the length of VAP treatment; reduction of the length of mechanical ventilation; reduction of ICU stay; reduction of hospital stay; reduction of mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220912055944N1
Registration date:2023-05-04, 1402/02/14
Registration timing:prospective
Last update:2023-05-04, 1402/02/14
Update count:0
Registration date
2023-05-04, 1402/02/14
Registrant information
Name
Hanieh Basirkazeruni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3666 4034
Email address
hany_med1384@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2024-05-09, 1403/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of symbiotics on preventing ventilator- associated pneumonia in children on mechanical ventilation
Public title
Study of the effect of symbiotics on preventing ventilator- associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children supported by mechanical ventilation for at least 48 hours and without primary immunodeficiency
Exclusion criteria:
Primary immunodeficiency
Age
From 1 month old to 9 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, the intervention group receives the drug and the control group receives nothing
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.MUI.MED.REC.1401.135
Health conditions studied
1
Description of health condition studied
Ventilator-associated pneumonia
ICD-10 code
J20-J22
ICD-10 code description
Other acute lower respiratory infections
2
Description of health condition studied
Duration of mechanical ventilation
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Duration of ICU stay
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Duration of hospital stay
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Mortality rate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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)
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
Duration of hospitalization
Timepoint
Beginning and end of the hospitalization
Method of measurement
Number of the days the patients were hospitalized
5
Description
Mortality rate
Timepoint
End of the study
Method of measurement
Counting the deaths
Intervention groups
1
Description
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.
Category
Prevention
2
Description
Control group: The patients in this group were received nothing after mechanical ventilation.