Determining the effect of probiotics in the treatment of jaundice in neonates admitted
Design
The sample size is 90 people, which includes two groups of 45 people, which will be the intervention and control group (receiving phototherapy).
Patients will be blocked by randomization and will be divided into two groups. Initially, the volume of blocks will be considered 6 and all text combinations from AAABBB will be listed and an exclusive code will be considered for each. Next, according to the sample size (90 people), 15 blocks will be selected and listed by simple randomization method. All processes will be performed under the supervision of an epidemiologist.
Settings and conduct
Study participants are blinded. Urmia University of Medical Sciences, Urmia Shahid Motahari Hospital
For both INTENSIVE phototherapy groups, the double 12-lamp device manufactured by Tucson will be used from the beginning of hospitalization. For the study group, in addition, 5 drops of reuteflor will be given orally in the morning and until the serum bilirubin level is cleared every hour. It will be measured at 0, 24, 48 and 72 hours after hospitalization and the number of hospitalization days and hospitalization hours will be recorded in two groups. All measurements will be done in one center by an experienced laboratory technician with the same kits.
Participants/Inclusion and exclusion criteria
Neonates with jaundice and hospitalized
Intervention groups
The sample size is 90 people, which includes two groups of 45 people, which will be the intervention and control group (receiving phototherapy).
Main outcome variables
Serum bilirubin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220425054656N1
Registration date:2022-11-04, 1401/08/13
Registration timing:retrospective
Last update:2022-11-04, 1401/08/13
Update count:0
Registration date
2022-11-04, 1401/08/13
Registrant information
Name
Nasim Khalilidizaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3328 4717
Email address
nasimkhalilidizaji@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotics in the treatment of jaundice
Public title
Evaluation of the effect of probiotics in the treatment of jaundice
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Semester infants with jaundice
Exclusion criteria:
Hospitalized infants with a diagnosis of jaundice who have sepsis
2 admitted with a diagnosis of jaundice who have respiratory distress
Increased jaundice with the necessary amounts for blood transfusion
Jaundice due to blood group incompatibility and RH
Direct hyperbilirubinemia
Infants with severe congenital anomalies
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were blocked by simple randomization method and divided into two groups. At first, the size of the blocks will be considered 6 and all possible combinations from AAABBB will be listed and an exclusive code will be considered for each one. Further, according to the sample size (90 people), 15 blocks will be selected by simple randomization method. (lottery) was selected and listed. All processes were done under the supervision of an epidemiologist and using random allocation software. Random allocation software version 1.0.0, which was created by M. Saghaei, department of anesthesia, Isfahan university of medical sciences, Isfahan, Iran, and is one of the most widely used software for randomization, which according to the sample size and the number of groups blocks and the size of the blocks completely randomly presents the number and combinations of the necessary blocks, in the order of the blocks and combinations given by the software and assigning exclusive codes for each, which these combinations and codes are hidden and only in It is the authority of the epidemiology consultant and the order of entry of people will be based on them, only if any complications or problems are observed in the continuation of the study, these codes will be referred to in order to identify the people.
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 Urmia University of Medical Sciences
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.UMSU.REC.1401.012
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
R17
ICD-10 code description
Hyperbilirubinaemia without mention of jaundice, not elsewhere classified
Primary outcomes
1
Description
Neonatal jaundice
Timepoint
0،24،48،72 hour
Method of measurement
Bilirubin detection kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: recipient of probiotic drops along with phototherapy, daily recipient of 6 drops of probiotics from Rotfeld company
Category
Rehabilitation
2
Description
Control group: Infants receiving phototherapy as a routine treatment for jaundice
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Hospital in Urmia
Full name of responsible person
nasim khalili dizaji
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 414 2718
Email
nasimkhalilidizaji@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
کامران دهقان
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 414 2718
Email
nasimkhalilidizaji@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Nasim khalili dizaji
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emergency Alley , Resalat Boulevard, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Nasimkhalilidizaji@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Kamran Dehghan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Emergency Alley , Resalat Boulevard, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
nasimkhalilidizaji@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nasim khalili dizaji
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Emergency Alley Boulevard, Urmia, Resalat
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
nasimkhalilidizaji@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data can be shared after being unidentified
When the data will become available and for how long
Access started after 1401
To whom data/document is available
Researchers working in institutions
Under which criteria data/document could be used
Type of analysis
From where data/document is obtainable
Dr. Nasim Khalili
What processes are involved for a request to access data/document