Comparison of the effect of simultaneous use of orlistat and phototherapy with standard therapy in reducing neonatal jaundice
Design
A clinical trial has been conducted with randomized control and intervention groups. The sample size consists of 64 neonates. Individuals will be randomly assigned to one of the two groups by using the table of random numbers.
Settings and conduct
The present study will be conducted at Qods Hospital of Qazvin. In the intervention group, Orlistat (6mg / kg dose) will be taken orally. The drug will be given to the infant in dissolved in distilled water and phototherapy will be performed according to the standard protocol. Bilirubin levels will be measured in both groups before and after 12 and 24 hours after treatment start. Finally, the data will be entered into SPSS software and statistical tests will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Term neonatal, neonatal weight between 2500- 4000 grams, 2-7 days old neonatal, and total serum bilirubin level 13-25 mg/dl.
Exclusion criteria: infants with sepsis, meningitis, congenital anomalies, dehydration, hemolytic disease, Conjugate hyperbilirubinemia.
Intervention groups
Intervention Groups will be included:
Group 1 (intervention): Treatment with Orlistat (product of Sanafi Co. at a dose of 6 mg/kg once as an oral consumption suspended in distilled water) and phototherapy (visible light with 490-490 nm wavelength).
Group 2 (Control): Treatment with phototherapy.
Main outcome variables
1- Total serum bilirubin
2- Serum conjugated bilirubin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190105042241N1
Registration date:2019-03-07, 1397/12/16
Registration timing:registered_while_recruiting
Last update:2019-03-07, 1397/12/16
Update count:0
Registration date
2019-03-07, 1397/12/16
Registrant information
Name
gelareh roozbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 4918
Email address
g.roozbahani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the simultaneous use of Orlistat and phototherapy with standard treatment in the decrease of neonatal jaundice
Public title
Neonatal Jaundice Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term neonatal
Neonatal weight between 2500- 4000 grams
2-7 days old neonatal
Total serum bilirubin level 13-25 mg/dl
Direct bilirubin level less than 2 mg/dL or less than 15% from total serum bilirubin
In the present study, individuals will be randomly assigned to one of the two intervention and control groups by using the table of random numbers. There is no precondition for assigning individuals to groups. The randomization unit is Individual. Every participant will have an equal chance of being in each of the groups. Allocation concealment samples are done by the people of the center that they do not have any information about the researcher's aim. The allocation of individuals to groups will be done in an unpredictable random sequence by using the table of random numbers. The path in the random numbers table will be from left to right. Even numbers will be considered for the intervention group and odd numbers for the control group.
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
Before starting treatment and 12 and 24 hours after starting treatment
Method of measurement
Standard protocol (Using diazo solutions and photometric method)
2
Description
Serum conjugated bilirubin
Timepoint
Before starting treatment and 12 and 24 hours after starting treatment
Method of measurement
Standard protocol (photometric method)
Secondary outcomes
1
Description
Length of hospitalization
Timepoint
End of study
Method of measurement
Based on hours
Intervention groups
1
Description
Intervention group: Orlistat (a product of Sanafi Co. LTD at a dose of 6 mg/kg once administered as an oral suspension) and phototherapy (visible light with a wavelength of 490-490 nm using the phototherapy machine made by Zardiran Company).
Category
Treatment - Drugs
2
Description
Control group: Phototherapy (visible light with a wavelength of 490-490 nm using the phototherapy machine made by Zardiran Company)
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
Murtaza Habibi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Qods Sq., Shahid beheshti Blvd., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
4595134159
Phone
+98 28 3333 4807
Email
mhabibi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Gelareh Roozbahani
Position
M.D. student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods Sq., Shahid Bahonar Blvd., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3333 7006
Email
g.roozbahani@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Gelareh Roozbahani
Position
M.D. student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods Sq., Shahid Bahonar Blvd., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3333 6003
Email
g.roozbahani@qums.ac.ir
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
Not applicable
Title and more details about the data/document
All data is published in Excel format without mentioning patient names.
When the data will become available and for how long
The data will be released from July 2022 for one month.
To whom data/document is available
Medical students, researchers at medical research centers and professors of medical sciences universities
Under which criteria data/document could be used
Comparison of data with other experimental data is allowed. If the article is published, mention should be made of the names of the persons who own the data.
From where data/document is obtainable
The main executor of clinical trial
What processes are involved for a request to access data/document
Submitting a request by the applicant and submitting a letter from the authorized centers.