The aim of this study was to determine the prophylactic effect of clofibrate in twin pregnancy very low birth weight (birth weight < 1500 gm) neonates hyperbilirubinemia. In a randomized double blind clinical trial 50 very low birth weight neonates who are twin pregnancy with single sex(male) entered to study. Healthy very low birth weight neonates who are admitted to NICU and are twin pregnancy with similar gendar as including and neonates with hemolysis, excessive external bleeding, G6PD, sepsis, infection, severe respiratory disease need to ventilation, congenital anomalies and metabolic diseases are excluded. Study participants receive either single dose clofibrate 100 mg/kg (clofibrat group n=25) or sterile water as volume as clofibrate (control group n=25) by orogastric tube. Serum bilirubin levels are measured at entrance, 24, 48, 72 and 96 hours of study. Duration of phototherapy also is recorded in two groups. Physical exam and liver function tests for drug side effects are controled
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811061162N15
Registration date:2011-01-26, 1389/11/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-26, 1389/11/06
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
2010-09-25, 1389/07/03
Expected recruitment end date
2011-08-25, 1390/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of clofibrate on prevention of jaundice in very low birth weight twin pregnancy neonates
Public title
Prophylactic effect of clofibrate on prevention of jaundice in very low birth weight twin pregnancy neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: twin pregnancy with same gender very low birth weight neonates who are admitted to NICU of Emamreza Hospital. These neonates are healthy, with birth weight equal or less than 1500 grams.
Exclusion criteria: Babies with hemolysis, excessive external bleeding, G6PD, sepsis, infection, severe respiratory disease need to ventilation, congenital anomalies and metabolic diseases are excluded
Age
From 1 year old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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 chancellor for research of Mashhad University of medical sciences
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
13131-91379
Approval date
2010-09-25, 1389/07/03
Ethics committee reference number
1978/511
Health conditions studied
1
Description of health condition studied
Very low birth weight hyperbilirubinemia
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight
Primary outcomes
1
Description
serum bilirubin
Timepoint
befor intervention,24,48,72 and 96 hours after intervention
Method of measurement
measurement of serum bilirubin (diazo method)
Secondary outcomes
1
Description
jaundice
Timepoint
before intervention,24,48,72 and 96 hours after intervention
Method of measurement
observation
Intervention groups
1
Description
Intervention group: 100 mg of clofibrate
Category
Prevention
2
Description
Control group: sterile water
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Research Center & NICU of Emaereza hospital
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 sciences
Full name of responsible person
Dr Jalil Tavakol Afshari
Street address
Ghoreshi bulding, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)