The aim of this study is evaluation the effect of Clofibrate on the prevention of jaundice in term neonates.
All term neonate (37 – 41 week of Gestational Age, 6/7) who are otherwise health and resulting from a non-complicated pregnancy, will be enrolled in the study. Exclusion criteria include: Term infants with overt jaundice in the first day after birth; Direct hyperbilirubinemia more than 1 mg/dl; Sick neonates; Infants born to mothers under phenobarbital treatment; Low birth weight neonate (birth weight less than 2500 gr); Preterm neonate (the gestational age less than 37 weeks) and neonates with Rh incompatibility; In this clinical trial neonates will be put into two groups; 40 neonates will receive one dose of oral Clofibrate (50 mgr per kgr) within first hour after birth and after first breast feed. Other 40 neonates won't take any medication and defined as control group. Both groups then will be followed closely for jaundice. The bilirubin level of two gropes will be measured by Bilirubinometers in 24, 48, and 72 hours after birth. The plasma level of bilirubin will be checked when the skin bilirubin are more than 10 mgr/dl. The primary level of total and direct bilirubin, blood group, RH, and G6PD level will be measured in umbilical cord blood sample. The mother’s blood group will be recorded using patient’s medical document review.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031312803N1
Registration date:2013-05-28, 1392/03/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-28, 1392/03/07
Registrant information
Name
Sadroddin Mahdipour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1324 6963
Email address
smb1355@gmail.com
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences is sponsoring the project.
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Clofibrate on the prevention of jaundice in healthy term neonate group)
Public title
Effect of clofibrate on the prevention of jaundice in term neonate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :All term neonate (37 – 41 week of Gestational Age, 6/7) who are otherwise health and resulting from a non-complicated pregnancy
Exclusion criteria include: Term infants with overt jaundice in the first day after birth; Direct hyperbilirubinemia more than 1 mg/dl; Sick neonates; Infants born from mothers under phenobarbital treatment; Low birth weight neonate (birth weight less than 2500 gr); Preterm neonate (the gestational age less than 37 weeks) and neonates with Rh incompatibility.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Babol University Of Medical Sciences
Street address
Babol University Of Medical Sciences, Ganjafroz street
City
Babol
Postal code
Approval date
2013-01-22, 1391/11/03
Ethics committee reference number
2006/30/ژ/پ
Health conditions studied
1
Description of health condition studied
neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Total Bilirubin
Timepoint
Umbillical cord and 24,48,72 hours after birhbirth bilirubin
Method of measurement
with Bilirubinometer
Secondary outcomes
empty
Intervention groups
1
Description
Prescription of Clofibrate(50 mg per kg of body weight ,orally) during the first hour after birth and after fist meal of breastfeeding in the intervention group
Category
Treatment - Drugs
2
Description
there is no intervention in the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Aiatollah Rohani Hospital
Full name of responsible person
Mrs Mariam Taheri
Street address
Nursery Ward, Aiatollah Rohani Hospital, Ganjafroz Street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences ,
Full name of responsible person
Dr Amrollah Mostafazadeh
Street address
Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr Sadroddin Mehdipour
Position
Neonatal Fellowship
Other areas of specialty/work
Street address
Amirkola Children Hospital
City
Amirkola
Postal code
Phone
+98 11 1325 2988
Fax
Email
smb1355@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol univesity
Full name of responsible person
Dr Yadollah Zahad Pasha
Position
Neonatologist
Other areas of specialty/work
Street address
Amirkola Children Hospital
City
Babol
Postal code
Phone
+98 11 1325 2988
Fax
Email
yzpasha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Sadroddin Mehdipour
Position
Neonatal Fellowship
Other areas of specialty/work
Street address
Amirkola Children Hospital-Amirkola
City
Babol
Postal code
Phone
+98 11 1325 2988
Fax
Email
smb1355@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)