Comparison of the effect of adding a single dose of fenofibrate to phenobarbital in the treatment of prolonged neonatal jaundice with phenobarbital alone
The aim of this study was to evaluate the simultaneous effect of single dose of fenofibrate and phenobarbital against phenobarbital alone on prolonged jaundice of mature (full term) neonates.
Design
Clinical trial with control group, with parallel groups, without blinding, simple randomized, phase 3 on 60 patients. Excel software rand function was used for randomization.
Settings and conduct
Sixty infants who referred to Dr. Golshan's office were selected from a statistical population of eligible individuals in a consecutive manner and then randomly (using a random number table) were divided into two groups of 30 each. After obtaining parental permission, the neonates were divided into two groups: phenobarbital or control group (n = 30) and phenobarbital + fenofibrate group (n = 30). Total bilirubin was measured in both groups during referral and 7 days after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All full-term infants (gestational age between 37 to 41 weeks), age between 14 to 40 days, weighing between 2500 to 4000 grams, Breastfed, containing total bilirubin 10 to 20 mg/dl, no Symptoms of hemolysis in a blood test, without symptoms of infectious disease or any abnormality
Conditions of absence: In case of clinical or laboratory signs of infection, any abnormalities, dehydration, glucose-6-phosphate deficiency, positive Combs test, history of phenobarbital administration by mother or infant, indirect bilirubin more than 2 mg/dL Total bilirubin more than 20 mg per deciliter
Intervention groups
The control group is given phenobarbital tablets for 5 days (first day 10 mg/kg then 5 mg/kg). The intervention group is given a single dose of fenofibrate (10 mg/kg) with phenobarbital tablets for 5 days.
Main outcome variables
Total bilirubin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201118049433N1
Registration date:2020-12-10, 1399/09/20
Registration timing:registered_while_recruiting
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Mohammad Golshan Tafti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 8060
Email address
mgolshan035@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-09, 1399/05/19
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding a single dose of fenofibrate to phenobarbital in the treatment of prolonged neonatal jaundice with phenobarbital alone
Public title
The effect of adding fenofibrate to phenobarbital in the treatment of prolonged neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants who are full-term (gestational age between 37 and 41 weeks)
All infants between the ages of 14 and 40 days
All infants weighing between 2500 and 4000 grams
Infants who are breastfed
All infants with total bilirubin 10 to 20 mg/dL
Infants who show no signs of hemolysis on a blood test
Infants who do not have symptoms of an infectious disease or any abnormality
Exclusion criteria:
Infants who are dehydrated
Infants who test positive for Coombs
Infants with indirect bilirubin more than 2 mg/dL
Age
From 14 days old to 40 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, we used a simple randomization method. The number of 60 eligible infants who referred to the neonatal clinic consecutively was numbered from 01 to 60 in order of referral time. Then the rand function of Excel software was used for randomization. The neonates were divided into two groups of 30 A(phenobarbital or control group) and B(fenofibrate+ phenobarbital 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 Islamic Azad University of Yazd
Street address
Research unit, Ali Ibn Abitaleb Medical School, Islamic Azad University Of Yazd, Shohada Gomnam Boulevard, Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877318
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.IAU.YAZD.REC.1399.035
Health conditions studied
1
Description of health condition studied
Prolonged neonatal jaundice
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total bilirubin
Timepoint
At the beginning of the study (before the intervention) and 7 days after the start of the procedure
Method of measurement
Bilirubin meter
Secondary outcomes
empty
Intervention groups
1
Description
In this group, phenobarbital tablets with a dose of 10 mg/kg on the first day and then with a dose of 5 mg/kg until the fifth day, are given orally daily.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, a single dose of fenofibrate capsules at a dose of 10 mg/kg with phenobarbital tablets at a dose of 10 mg/kg on the first day and then at a dose of 5 mg/kg until the fifth day, is given orally daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mohammad Golshan Tafti's office
Full name of responsible person
Dr. Mohammad Golshan Tafti
Street address
Dr. Golshan office, Golchin Ave., Taleghani Blvd., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915145653
Phone
+98 35 3725 8060
Email
mgolshan035@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Seyed Mohammad Reza Mortazavizadeh Yazdi
Street address
Research unit, Ali Ibn Abitaleb Medical School, Islamic Azad University Of Yazd, Shohada Gomnam Boulevard, Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877318
Phone
+98 35 3821 0540
Email
mortazavizadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammad Golshan Tafti
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr. Golshan office, Golchin Ave., Taleghani Blvd., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915145653
Phone
+98 35 3725 8060
Email
mgolshan035@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Golshan Tafti
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr. Golshan office, Golchin Ave., Taleghani Blvd., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915145653
Phone
+98 35 3725 8060
Email
mgolshan035@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Golshan Tafti
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr. Golshan office, Golchin Ave., Taleghani Blvd., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915145653
Phone
+98 35 3725 8060
Email
mgolshan035@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