To compare the effect of fenofibrate versus clofibrate on serum bilirubin level in term neonates with hyperbilirubinemia
Design
A randomized clinical double blinded trial with two groups of 40 neonates (total 80 neonates) in fenofibrate and clofibrate groups
Settings and conduct
At Amirkola Children Hospital all term neonates admitted for phototherapy with hyperbilirubinemia randomly were assigned to two groups, fenofibrate and clofibrate. All neonates fed by their mother's milk. Fenofibrate (Sobhan Co., Iran) in liquid form
( 20 mg/ml ) 10 mg/kg single oral dose in fenofibrate group and clofibrate ( Zahravi Co., Iran ) in liquid form (100 mg/ml ) 100 mg/kg single oral dose was given to another group after the initiation of phototherapy. The serum bilirubin level was checked daily by biochemical kit ( made in Iran ) and they were discharged after reaching the serum bilirubin level to < 10 mg/dl.
Participants/Inclusion and exclusion criteria
Healthy term, otherwise normal neonates with hyperbilirubinemia
Intervention groups
Fenofibrate and clofibrate groups
Main outcome variables
The serum bilirubin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044158N1
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Ghorban Mohammad Nazari Komeshtappeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3235 4953
Email address
gh.nazari@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-08, 1398/08/17
Expected recruitment end date
2020-02-08, 1398/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the Effect of Fenofibrate and Clofibrate on Term Neonates with Hyperbilirubinemia
Public title
Comparison between the Effect of Fenofibrate and Clofibrate on Term Neonates with Hyperbilirubinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term neonates(37 weeks to 41 weeks and 6 days) that their ages are more than 72 hours.
They were admitted for jaundice, total bilirubin serum more than 15 mg/dl.
They were otherwise healthy.
They did not receive therapy other than phototherapy.
Exclusion criteria:
Premature neonates
IUGR infants
Neonates with congenital anomaly
Neonates with blood group and RH incompatibility
Neonates with G6PD deficiency
Neonates with history of maternal phenobarbital consumption
Neonates with respiratory distress and signs and symptoms of sepsis
Age
From 3 days old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The neonates were allocated using a table of random numbers.
In a table composed of the numbers from zero to nine after closing eyes, we pointed on a number, then moved horizontally.
The number from zero to four allocated to clofibrate group and the number from five to nine allocated to the fenofibrate group.
This work was continued until the end of the sample size was achieved.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participant neonates blindly allocated to each group, the researcher is not aware of group assignment, and also the statistician is kept blind about the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciencese
Street address
Vice-chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2019-11-03, 1398/08/12
Ethics committee reference number
IR. MUBABOL. HRI. REC. 1398. 219
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
Serum bilirubin level
Timepoint
Admission time, second day, third day, discharge time
Method of measurement
Spectrophotometric method with the biochemical kit ( made in Iran )
Secondary outcomes
1
Description
Duration of need to phototherapy and hospital stay
Timepoint
From the time of admission until discharge
Method of measurement
Duration of time by hour
Intervention groups
1
Description
Fenofibrate group: single dose of oral fenofibrate (Sobhan Co., Iran) in liquid form, containing 20 mg/ml, with a dose of 10 mg/kg was given at the time of admission. Standard phototherapy treatment was done. All the babies fed by their own mothers milk. Serum bilirubin level was checked at least every day at Amirkola Children's Hospital laboratory (biochemical kit, Iran) and reported as mg/dl. After reaching the serum bilirubin level to less than 10 mg/dl, neonates were discharged from hospital.
Category
Treatment - Drugs
2
Description
CClofibrate group: single dose of clofibrate (Zahravi Co., Iran) in liquid form, containing 100 mg/ml, with a dose of 100 mg/kg was given at the time of admission. Standard phototherapy treatment was done. All the babies fed by their own mothers milk. Serum bilirubin level was checked at least every day at Amirkola Children's Hospital laboratory (biochemical kit, Iran) and reported as mg/dl. After reaching the serum bilirubin level to less than 10 mg/dl, neonates were discharged from hospital.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children's Hospital
Full name of responsible person
Mousa Ahmadpour-kacho
Street address
No 19, Amirkola Children's Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
mousa_ahmadpour@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9591
Fax
+98 11 3219 4727
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mousa Ahmadpour-kacho
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children's Hospital, Amirkola
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
mousa_ahmadpour@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mousa Ahmadpour-kacho
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children's Hospital, Amirkola
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
mousa_ahmadpour@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ghorban Mohammad Nazari Komeshtappeh
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children's Hospital, Amirkola
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
gh.nazari@mubabol.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
Yes - There is a plan to make this available
Title and more details about the data/document
The outcomes including the serum bilirubin level in two groups at the end of the trial .
When the data will become available and for how long
Six months after the publication of the paper.
To whom data/document is available
Now for the researcher at the scientific and academic centers.
Under which criteria data/document could be used
For using the data to answer the unsolved questions regarding the research.
What processes are involved for a request to access data/document
Sending an Email to the corresponding person, explaining the request, recognizing the applicant by the corresponding person ,then sending the data to him/her.