The Effect of Oral Zinc on Morbidity and Mortality in Neonatal Sepsis
Design
. Two arm parallel group randomised double blinded trial
Settings and conduct
The aim of this study was to evaluate the effect of oral zinc sulfate on mortality and morbidity in neonatal sepsis admitted to NICU of Shahrekord Hajar Hospital during 2016-2017.
Parents of neonates and data analyzer and committee on safety and supervision of data were kept unaware of the groups their neonate was allocate to.
Participants/Inclusion and exclusion criteria
neonates with sepsis are enrolled and neonates with congenital anomaly ,GA<32 weeks, NEC excluded from trial
Intervention groups
The first group received the oral zinc sulfate for 10 days, together with the antibiotic therapy, and the second group (the control group) received the classic treatment of sepsis.
Main outcome variables
mortality
morbidity
Hospitalization period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180915041040N2
Registration date:2019-08-16, 1398/05/25
Registration timing:retrospective
Last update:2019-08-16, 1398/05/25
Update count:0
Registration date
2019-08-16, 1398/05/25
Registrant information
Name
Roya Choopani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
choopani.r@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-10, 1395/03/21
Expected recruitment end date
2017-10-02, 1396/07/10
Actual recruitment start date
2016-06-12, 1395/03/23
Actual recruitment end date
2017-08-23, 1396/06/01
Trial completion date
2017-11-12, 1396/08/21
Scientific title
The Effect of Oral Zinc on Reduction of Mortality in Newborns with Neonatal Sepsis
Public title
The Effect of Oral Zinc on Neonatal Sepsis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
neonate less than 28 day old
neonate with sepsis
Exclusion criteria:
parental dissatisfaction
threatening congenital anomalies
asphyxia(resuscitation at birth more than 15 minutes or 10-minute Apgar score less than 5)
Gestational age less than 32 weeks
neonatal necrotizing enterocolitis
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Parents of neonates and data analyzer and committee on safety and supervision of data were kept unaware of the groups their neonate was allocate to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Hajar hospital,parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874119
Approval date
2017-05-29, 1396/03/08
Ethics committee reference number
IR.SKUMS.REC.1396.49
Health conditions studied
1
Description of health condition studied
neonatal sepsis
ICD-10 code
ICD-10 code description
2
Description of health condition studied
neonatal sepsis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mortality
Timepoint
Neonatal period
Method of measurement
Number
Secondary outcomes
1
Description
Hospitalization period
Timepoint
Neonatal period
Method of measurement
Day
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Roya Choupani
Street address
Hajar Hospital ,Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
choopani.r@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Kamal Solati
Street address
Kashani Street,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Web page address
https://skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya.Choopani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available