This randomized clinical trial study was performed to assess effect of different dose of clofibrate on neonatal jaundice.The inclusion criteria included: age of 2 to 29 days; full term newborn (gestational age between 38 to 40 weeks); weight of 2500 to 4000 gr; having indirect hyperbilirubinemia (TSB>16mg/dl); absence of hemolysis, ABO or Rh incompatibility; negative coomb’s test; reticulocyte count less than 5%.
We enrolled 132 neonates with non-hemolytic indirect hyperbilirubinemia admitted in the neonatal ward of Beasat hospital in Hamadan city, during a nine-month period. The patients were randomly assign to three groups : control group receiving only phototherapy; intervention group 1 receiving a single low dose of oral clofibrate (25 mg/kg) plus phototherapy; intervention group 2 receiving a single moderate dose of oral clofibrate (50 mg/kg) plus phototherapy. Total and indirect bilirubin level was measured in all groups at baseline and 12, 24, 36 and 48 hours after treatment. All neonates were visited in outpatient clinic two days after discharge.
No adverse effects were seen subsequent to clofibrate administration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092910933N1
Registration date:2012-10-25, 1391/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-25, 1391/08/04
Registrant information
Name
Fatemeh Eghbalian
Name of organization / entity
Hamadan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 3978
Email address
eghbalian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University Of Medical Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of low dose vs moderate dose clofibrate on decreasing serum bilirubin in healthy full term neonates
Public title
Evaluating the effect of low dose vs moderate dose clofibrate on decreasing serum bilirubin in healthy full term neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: (a) age of 2 to 29 days; (b) full term newborn (gestational age between 38 to 40 weeks); (c) weight of 2500 to 4000 gr; having indirect hyperbilirubinemia (TSB>16 mg/dl) ; (d) absence of hemolysis, ABO or Rh incompatibility; (e) negative coomb’s test; (f) reticulocyte count less than 5%.
Exclusion criteria : The neonates with sign of sepsis, electrolyte impairment, any congenital anomalies or disease, seizure, formula feeding, hemolytic disease and those who need exchange transfusion were excluded from the study.
Age
From 1 year old to 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
132
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Mahdie Ave, Hamadan university of Medical sciences, Hamedan, Iran
City
Hamedan
Postal code
6514845411
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
پ/16/35/9/116602
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
P59.9 Neonatal jaundice, unspecified
Primary outcomes
1
Description
Bilirubin
Timepoint
Total and indirect bilirubin levels were measured at the beginning of treatment and then 12, 24, 36 and 48 hours later
Method of measurement
RA1000 Techinca
Secondary outcomes
1
Description
Bilirubin
Timepoint
Total and indirect bilirubin levels were measured at the beginning of treatment and then 12, 24, 36 and 48 hours later
Method of measurement
RA1000 Techinca
Intervention groups
1
Description
control group receiving only phototherapy
Category
Treatment - Drugs
2
Description
intervention group 1 receiving a single low dose of oral clofibrate (25 mg/kg) plus phototherapy
Category
Treatment - Drugs
3
Description
intervention group 2 receiving a single moderate dose of oral clofibrate (50 mg/kg) plus phototherapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bessat Hospital - Neonatal Ward
Full name of responsible person
Dr Fatemeh Eghbalian
Street address
Motahari Ave, Bessat Hospital, Hamedan, Iran
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Hydar Tavilani
Street address
Mahdie Ave, Hamadan University of Medical Sciences,Hamadan,Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?