The aim of this study was to determine the prophylactic effect of clofibrate in very low birth weight (birth weight < 2500 gm)neonate's hyperbilirubinemia. In a randomized double blind clinical trial 52 very low birth weight neonates were elected. Healthy very low birth weight neonates who were admitted in NICU were included and neonates with hemolysis, infection, congenital anomalies and metabolic diseases were excluded. Study participants received either single dose of clofibrate 100 mg/kg (n=26) or sterile water as volume as clofibrate (n=26) by Orogastric tube. Serum bilirubin levels were measured at entrance, 24, 48, 72 and 96 hours after intervention. Duration of phototherapy also was recorded in two groups. Physical exam and liver function tests for drug side effects were controlled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706311162N5
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
2006-04-06, 1385/01/17
Expected recruitment end date
2007-01-07, 1385/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of colofibrate in very low birth weight neonates' hyperbilirubinemia
Public title
Prophylactic effect of clofibrate in very low birth weight neonates' hyperbilirubinemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion:low birth weight neonates who were admitted to NICU of Emamreza Hospital.These neonates were healthy, breastfed with birth weight equal or less than 2500 grams.
exclusion: Babies with hemolysis, infections, congenital anomalies and metabolic diseases were excluded
Age
From 1 year old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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 chanceler of Mashhad University of Medical Sciences
Street address
Ghoreshi bilding-Daneshgah street-Mashhad-Iran
City
Mashhad
Postal code
9137913316
Approval date
2006-04-19, 1385/01/30
Ethics committee reference number
5/6833
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia in low birth weight neonates
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum Bilirubin
Timepoint
before intervention, 24, 48, 72, and 96 hours after intervention
Method of measurement
measurment of serum bilirubin (diazo method)
Secondary outcomes
1
Description
Incidence of jaundice in low birth weight neonates
Timepoint
before intervention,24,48,72 and 96 hours after intervention
Method of measurement
Physical examination (yes/no)
Intervention groups
1
Description
100 mg/kilogram clofibrate
Category
empty
2
Description
The same volume of strile water as Placebo
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?