The goal of this study was to evaluate the effect of Clofibrate in the treatment of jaundice in low birth weight newborns. In a randomized double blind placebo – controlled study, low birth weight infants with the complaint of icter are selected. Study participants receive either clofibrate 100 mg/kg or distilled water once time/ day. Then they receive phototherapy and their bilirubin level is measured in 12hr, 24hr, 48hr, and 72 hr afterword.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138708291162N8
Registration date:2009-01-20, 1387/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-01-20, 1387/11/01
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 science
Expected recruitment start date
2006-09-30, 1385/07/08
Expected recruitment end date
2007-04-27, 1386/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of clofibrate in low birth weight neonates' hyperbilirubinemia
Public title
Effect of clofibrate in low birth weight neonates' hyperbilirubinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All neonates with birth weight less than 2500gr who have icter.
Exclusion criteria: the presence of a hemolytic, infection, congenital anomaly or metabolic disorder and undergoing mechanical ventilation.
Age
From 2 years old to 28 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
vice chanceler of mashad university of medical scienc
Street address
ghoreshi bilding-daneshgah street
City
mashhad
Postal code
91379-13131
Approval date
empty
Ethics committee reference number
12502/824
Health conditions studied
1
Description of health condition studied
low birth weight
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight
2
Description of health condition studied
hyperbilirubinemia
ICD-10 code
P59.0
ICD-10 code description
Neonatal jaundice associated with preterm delivery
Primary outcomes
1
Description
decreasing of serum bilirubin
Timepoint
befor intervention and 12,24,48,72 and 96 hours after intervention
Method of measurement
measurment of serum bilirubin (diazo method)
Secondary outcomes
1
Description
tereatment of jaundice of neonate
Timepoint
befor intervention and 24,48,72 and 96 hours after intervention
Method of measurement
decreasing of jaundice and bilirubin level in blood serum
Intervention groups
1
Description
in cases: clofibrate 100 mg/kg once time/ day
Category
Treatment - Drugs
2
Description
in controls: distilled water once time/ day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Emaereza hospital-Neonatal Research Center
Full name of responsible person
dr.Ashraf mohammadzadeh
Street address
Neonatal research center- NICU- Emamreza hospital
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
mashhad university of medical science
Full name of responsible person
Dr jalil tavakol afshari
Street address
ghoreshi bulding-daneshgah street-mashhad-Iran
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?