The aim of this study was to determine the therapeutic effect of clofibrate in healthy term jaundiced neonates. Healthy, breastfed neonates,uncomplicated delivery between 38 th and 41 st weeks gestational age were included and babies with congenital anomaly, hemolytic disease (Rh or ABO incompatibility and a positive coombs' test), infection (congenital or acquried), dehydration, G6PD deficiency and conjugated bilirubin>2.0 mg/dl or exceeding 15% of total serum bilirubin were excluded. Thirty neonates (treatment group) were treated with a single oral dose of clofibrate (100 mg/kg) plus phototherapy while another 30 neonates (control group) received only phototherapy. The mean plasma total bilirubin levels were measured at 12, 24 and 48 hours after treatment. Duration of phototherapy also was recorded. Phyisical examination and liver function tests were controlled for possible side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706261162N4
Registration date:2008-10-28, 1387/08/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-10-28, 1387/08/07
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2002-11-02, 1381/08/11
Expected recruitment end date
2003-07-09, 1382/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Clofibrate in Jaundiced term Newborns
Public title
Effect of Clofibrate in Jaundiced Term newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: healthy jaundiced, breastfed neonates, delivered between 38th and 41st week of gestational age after an uncomplicated pregnancy and serum bilirubin(TSB) between 17 and 29.9 mg/dl ,age less than 28 days
exclusion criteria: congenital anomaly, hemolytic disease (Rh or ABO incompatibility and a positive coombs' test), infection (congenital or acquired), dehydration, G6PD deficiency and conjugated bilirubin>2.0 mg/dl or exceeding 15% of total serum bilirubin,age more than 28 days
Age
From 3 years old to 19 years 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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor of Mashhad University of Medical Sciences
Street address
Ghoreshi bulding-Daneshgah Street-Mashhad-Iran
City
Mashhad
Postal code
91379-13131
Approval date
2002-12-02, 1381/09/11
Ethics committee reference number
15169/824
Health conditions studied
1
Description of health condition studied
Jaundice in healthy, term newborn
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum bilirubine
Timepoint
Before intervention-12,24 and 48 after intervention
Method of measurement
Measuring serum bilirobin(diazo method)
Secondary outcomes
1
Description
Duration of need to phototrapy
Timepoint
daily
Method of measurement
Duration of phototherapy (days)
Intervention groups
1
Description
Phototherapy + clofibrate(100 mg/kg, single dose)
Category
empty
2
Description
Phototherapy
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Emaereza hospital-Neonatal Research Center
Full name of responsible person
Ashraf Mohammadzadeh
Street address
Neonatal research center- NICU- Emamreza hospital-mashhad-Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Street address
City
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?