Determining the effect of probiotics in the prevention of septicemia in preterm infants
Design
Clinical trial with control group, with parallel groups, phase 3 number of 32 infants in each group. Allocation of samples to intervention groups is done by doctor's order
Settings and conduct
This study is conducted on premature infants born in Qazvin Kosar Hospital. The intervention group receives daily five drops of pedilact donated by Danesh Banyan Bio Fermentation Company (including species of Lactobacillus rotheri, Lactobacillus rhamnosus, Bifidobacterium infantis) and the control group receives routine treatments without probiotics and during hospitalization and discharge by comparing the following cases Placed:
1. The amount of CBC including WBC, PLT, Hb
2. The amount of CRP
3. Vital signs
4. Amount of urine culture
5. Duration of hospitalization
6. Duration of reaching full nutrition
7. Amount of blood culture
8. Weight at the time of discharge
Participants/Inclusion and exclusion criteria
Inclution criteria: All infants aged less than 37 weeks and weighing less than 2500 grams
Exclusion criteria: infants who have sepsis due to maternal infection such as PROM and maternal urinary infection, infants who are placed under ventilator
Intervention groups
Intervention group probiotics, control group without probiotics
Main outcome variables
septicemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240213060996N1
Registration date:2024-04-02, 1403/01/14
Registration timing:prospective
Last update:2024-04-02, 1403/01/14
Update count:0
Registration date
2024-04-02, 1403/01/14
Registrant information
Name
Amirreza Pourfaraj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
arpourfaraj@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of probiotics in the prevention of septicemia in preterm infants
Public title
Investigating the effect of probiotics in septicemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infants who are less than 37 weeks old and weigh less than 2500 grams
Exclusion criteria:
infants under 32 weeks and over 37 weeks
infants who have sepsis due to maternal infection such as PROM and maternal urinary infection
infants who are placed under a ventilator
Parents' unwillingness to participate in the study
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2024-01-21, 1402/11/01
Ethics committee reference number
IR.QUMS.REC.1402.343
Health conditions studied
1
Description of health condition studied
Neonatal septicemia
ICD-10 code
P36.9
ICD-10 code description
Bacterial sepsis of newborn, unspecified
2
Description of health condition studied
Neonatal premature
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Neonatal septicemia
Timepoint
Measurement of CBC, CRP, vital signs, urine culture, duration of hospitalization, duration of full nutrition, blood culture and weight during hospitalization and at the time of discharge.
Intervention group: Probiotic recipient that receive five drops of pedilact donated to the hospital by Danesh bonian zist takhmir Company (including Lactobacillus reuteri, Lactobacillus rhamnosus, Bifidobacterium infantis)
Category
Treatment - Drugs
2
Description
Control group: No probiotics that get routine treatments without probiotics
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Amirreza Pourfaraj
Street address
Kosar Ave., Taleghani Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
Hoskosar@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amirreza Pourfarej
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
arpourfaraj@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amirreza Pourfaraj
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
arpourfaraj@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amirreza Pourfaraj
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
arpourfaraj@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available