Evaluation of effect of vitamin E in serum bilirubin level in preterm neonates with gestational age between 34 and 37 weeks
Design
This randomized clinical trial was conducted to evaluate effect of vitamin E in prevention of hyper billirubinemia in preterm newborn with gestational age between 34 to 37 weeks born in Alzahra and Shahidbeheshti Hospital affiliated to Isfahan University of Medical Sciences. written informed consent was taken from the child's parents. The infants were randomly allocated to either the case or the control group by a simple randomization method using a table of random numbers. One hundred neonates with gestational age between 34 to 37 weeks were enrolled in this study. The neonates were randomly divided in two groups matched for age and gender. Immediately after birth For the cases group (consist of 50 newborn) 10 units of vitamin E (1 cc of vitamin E per a drop) and in the control group (consist of 50 newborn) 1 cc distilled water was administered orally for five days. In the 0,24,48,72 and 96 Hour of life, Transcutaneous Billirubinometery was conducted to evaluate level of bilirubin in neonates of two groups. The results was analyzed via t-test and x2-test. P value less than 0/05 was considered significant.
Settings and conduct
Alzahra and Shahid beheshti Hospitals in Isfahan
Participants/Inclusion and exclusion criteria
Preterm newborns with GA between 34 to 37 weeks
Exclusive breast feeding
Apgar score> 7 in fifth minute
lack of neonatal sepsis
lack of abdominal distentions or lavage
lack of history of exchange transfusion in previous sibling
Intervention groups
For the cases group (consist of 50 newborn) 10 units of vitamin E (1 cc of vitamin E per a drop) and in the control group (consist of 50 newborn) 1 cc distilled water was prescribed orally for five days
Main outcome variables
Neonatal Jaundice
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150423021910N4
Registration date:2019-01-04, 1397/10/14
Registration timing:registered_while_recruiting
Last update:2019-01-04, 1397/10/14
Update count:0
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
Behzad Barekatain
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6670
Email address
b_barekatain@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of vitamin E in serum bilirubin level in preterm neonates with gestational age between 34 and 37 weeks
Public title
Effect of Vit E on billirubin level in preterm newborns
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
preterm newborns with GA between 34 to 37 weeks
Exclusive breast feeding
Apgar score > 7 at fifth minute of life
Exclusion criteria:
lack of abdominal distention or lavage
lack of history of exchange transfusion in previous siblings
lack of neonatal sepsis
Age
From 1 day old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
5
Measurement of billirubin via Transcutaneous Billirubinometer
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random number was used. We use 100 tumultuous numerical table and we selected columns in the form of decussate and assigned its numbers to each groups (intervention and control groups)
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study the student and neonatal unit staffs dont know which types of drugs (Vit E or placebo) is prescribed. Transcutaneous Billirubinometery was performed by student that did not know which type of drugs prescribed by physician.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerib boulevard, Isfahan University of Medical Scienses
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-05-07, 1396/02/17
Ethics committee reference number
IR.MUI.REC.1396.3.071
Health conditions studied
1
Description of health condition studied
Neonatal Jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Neonatal Jaundice
Timepoint
In 0 , 24 , 48 , 72 , 96 Hours
Method of measurement
Transcutaneous Billirubinometer
Secondary outcomes
1
Description
Sepsis
Timepoint
During Study
Method of measurement
Clinical Sign and Blood Culture
Intervention groups
1
Description
Intervention group: In Intervention group we prescribed 10 unit of Vit E ( equall to 1 cc) orally once in day for 5 days
Category
Prevention
2
Description
Control group: In control group we prescribed 1 cc of distilled water orally once in day for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Behzad Barekatain
Street address
Sofeh street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3668 5555
Email
b_barekatain@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Shahidbeheshti Hospital
Full name of responsible person
Behzad Barekatain
Street address
Felezi Bridge, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3236 7001
Email
b_barekatain@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooi Javanmard
Street address
Hezarjerib boulevard, Isfahan University of Medical Scienses
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
b_barekatain@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?