Evaluating the therapeutic effect of ursodeoxycholic acid on the reduction of serum bilirubin in neonates with prolonged jaundice: A randomized controlled clinical trial study
The aim of this study is to investigate the therapeutic effects of ursodeoxycholic acid on the reduction of serum bilirubin in a different target group, i.e. infants with prolonged jaundice who are hospitalized and not undergoing phototherapy.
Design
A paralleled controlled randomized clinical trial, without blinding, phase 3 on 58 patients. Four random blocks method is used for randomization.
Settings and conduct
A randomized clinical trial will be done at 17 Shahrivar Hospital, Rasht, after obtaining informed consent from parents. It is a non-blinded study.
Intervention group: Administration of ursodeoxycholic acid capsules with a dose of 10 mg per kilogram of baby's weight daily in two divided doses to the intervention group for 5 days dissolved in cooled boiled water.
Control group: No medication is prescribed to the control group and they receive the recommended expectant treatment and monitoring.
Main outcome variables
Total and direct serum bilirubin on the day of the visit and 5 days after the intervention and drug administration and checking the reduction of bilirubin and comparing the numbers in 2 groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180228038895N2
Registration date:2023-06-24, 1402/04/03
Registration timing:registered_while_recruiting
Last update:2023-06-24, 1402/04/03
Update count:0
Registration date
2023-06-24, 1402/04/03
Registrant information
Name
Seyedeh Azadeh Hosseini Nouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9026
Email address
dr.azadehoseini@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-31, 1402/03/10
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the therapeutic effect of ursodeoxycholic acid on the reduction of serum bilirubin in neonates with prolonged jaundice: A randomized controlled clinical trial study
Public title
Evaluating the therapeutic effect of ursodeoxycholic acid on the reduction of serum bilirubin in neonates with prolonged jaundice
Conjugated hyperbilirubinemia (direct bilirubin above 1)
Disruption of TSH and T4
Clinical evidence of infection
Urinary tract infection
Sick neonates
Age
From 14 days old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process will be carried out under the supervision of the project manager and by her and with the direct supervision of the statistician and the supervisor. Children with admission criteria based on daily visits to the children's clinic are included in the study through consecutive sampling. For randomization, the quadruple random block method is used.
According to the sample size of 58 and equal to 29 people in each group, 16 blocks of 4 complete blocks and one double block will be selected. The random allocation of samples is based on the sequence list that is done through the random block allocation software. Children who meet the entry criteria are randomly assigned to Group A (ursodeoxycholic acid) and Group B (control) based on the list.
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 Guilan University Of Medical Sciences
Street address
Siadati Ave, Namjoo Blvd
City
Rasht
Province
Guilan
Postal code
441774349
Approval date
2023-05-31, 1402/03/10
Ethics committee reference number
IR.GUMS.REC.1402.110
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Total and direct serum bilirubin
Timepoint
On the day of visit and 5 days after the intervention
Method of measurement
Measurement of serum bilirubin level in serum sample in laboratory with kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of ursodeoxycholic acid capsules with a dose of 10 mg per kilogram of baby's weight daily in two divided doses to the intervention group for 5 days dissolved in cooled boiled water.
Category
Treatment - Drugs
2
Description
Control group: No medication is prescribed to the control group and they receive the recommended expectant treatment and monitoring.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital.
Full name of responsible person
Seyedeh Azadeh Hosseini Nouri
Street address
Siadati Alley, Namjoo St, Gaz Square
City
Rasht
Province
Guilan
Postal code
4167811969
Phone
+98 13 3336 9026
Email
dr.azadehoseini@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Siadati
City
Rasht
Province
Guilan
Postal code
4167811968
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Azadeh Hosseini Nouri
Position
Proffessor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
17shahrivar hospital, Siadati ave., Namjoo street, Gaz square
City
Rasht
Province
Guilan
Postal code
4167811969
Phone
+98 13 3336 9026
Fax
Email
Dr.azadehoseini@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Azadeh Hosseini Nouri
Position
Proffessor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
17shahrivar hospital, Siadati ave., Namjoo street, Gaz square
City
Rasht
Province
Guilan
Postal code
4167811969
Phone
+98 13 3336 9026
Fax
Email
Dr.azadehoseini@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Azadeh Hosseini Nouri
Position
Proffessor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
17shahrivar hospital, Siadati ave., Namjoo street, Gaz square
City
Rasht
Province
Guilan
Postal code
4167811969
Phone
+98 13 3336 9026
Fax
Email
Dr.azadehoseini@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD