The purpose of this study that will be done in Kermanshah Medical University is to evaluate the effect of oral zinc sulfate on transcutaneus bilirubin in healthy term neonates . The main inclusion criteria include: Term newborns with birth weight>2500, breast feeding and postnatal age less than24 h of life. exclusion criteria : congenital anomaly, cephalhematoma .blood group incompatibility ,sepsis, formula feeding, exchange transfusion in previous sibling.The sample size include 124 neonates. whom are randomly assigned into two different groups.control group and treatment group . Normal care is give to the control group. treatment group, were given 5 mg of zinc sulfate daily till day fifth of age . In both group transcutaneous bilirubin level measured from the first day to the fifth day postnatally. The main outcome of this study was to see the effect of oral zinc sulfate , on the level of transcutaneous bilirubin.The neonates were checked for the frequency of stool.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110084961N4
Registration date:2013-05-20, 1392/02/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-20, 1392/02/30
Registrant information
Name
Homa Babaei
Name of organization / entity
Kermanshah University of Medical Secinces
Country
Iran (Islamic Republic of)
Phone
00988314276303 داخلی 2292
Email address
homa_babaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-01-04, 1391/10/15
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey of the efficacy of oral zinc sulfate on transcutaneus bilirubin in healthy term neonates
Public title
A survey of the efficacy of oral zinc sulfate on transcutaneus bilirubin in healthy term neonates .
Purpose
Prevention
Inclusion/Exclusion criteria
The main inclusion criteria included:healthy term newborn with birth weight>2500, breast feeding and postnatal age less than 24 h. and exclusion criteria were : congenital anomaly, cephalhematoma،blood group incompatibility ,infection, formula feeding, exchange transfusion in previous sibling .
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
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
Kermanshah University of Medical Sciences
Street address
Building No=2,Shahid Beheshti Avenue, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-04-27, 1392/02/07
Ethics committee reference number
7/420/پ
Health conditions studied
1
Description of health condition studied
Neonata l Hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Transcutaneus Bilirubin
Timepoint
Each 24h
Method of measurement
By Bilimeter
Secondary outcomes
1
Description
Stool frequency
Timepoint
Each 24 h
Method of measurement
Inspection by Mother
Intervention groups
1
Description
Newborns in the control group underwent routine daily care and transcutaneous bilirubin level measured (from the first day to the fifth day postnatal) daily .
Category
Prevention
2
Description
Treatment group, were given 5 mg of zinc sulfate daily till day fifth of age . transcutaneous bilirubin level measured from the first day to the fifth day postnatally
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Deputy of Research, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei, MD
Position
Neonatologist
Other areas of specialty/work
Street address
Department of Pediatrics, Imam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
671441533
Phone
+98 83 1427 6303
Fax
Email
Homa_Babaei @kums.ac.ir Homa_Babaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei, MD
Position
Neonatologist
Other areas of specialty/work
Street address
Department of Pediatrics, Imam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
6714415333
Phone
+98 83 1427 6303
Fax
Email
Homa_Babaei@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei
Position
Neonatologist
Other areas of specialty/work
Street address
Department of pediatrics, Imam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
6714415333
Phone
+98 83 1427 6303
Fax
Email
Homa_Babaei@kums.ac.ir Homa_ Babaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)