Protocol summary

Summary
.The purpose is efficasy of zinc sulfate in reducing unconjugated hyperbilirubinemia in premature neonate.Its a randomized ,double blinded and controll with placebo study.Inclusion criteria:premature neonate with GA30-37week/weight1500-2500 exclusion criteria:hemolysis or sepsis,abnormality,dehydration,G6PD,ABOmissmatch,positive coombs,history of consumption phenobarbital by mother,IUGR,ventilation,NPO.we have 2 group:zinc sulfate and pacebo. all of neonate will treat with photothrapy.neonate in sulfate group reciecive 1mg/kg zincsulfate more than photo.in other group neonatewill recieve 1mg/kg placebo more than photo.prescription is oral with syrang and every 6 hours until the end of phototherapy.measurment of the level of bilirubin is the bigining of admission then 6 hours after that and then daily.Target sample size is 60.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120825439N1
Registration date: 2016-02-21, 1394/12/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-21, 1394/12/02
Registrant information
Name
SeyyedehHoda Khatib Masjedi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3604 3228
Email address
hodakhatib@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of zinc sulfate in reducing unconjugated hyperbilirubinemia in premature neonate in NICU
Public title
Efficacy of zincsulfate in icter
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:premature neonate with GA30-37week;weight1500-2500 exclusion criteria:hemolysis; o sepsis;abnormality;dehydration;G6PD;ABOmissmatch;positive coombs;history of consumption phenobarbital by mother;IUGR;ventilation;NPO
Age
To 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Birjand University of Medical Sciences
Street address
ghafari aveniue
City
Birjand
Postal code
9717853577
Approval date
2015-10-31, 1394/08/09
Ethics committee reference number
ir.bums.1394.51

Health conditions studied

1

Description of health condition studied
indirect hyperbilirubinemia
ICD-10 code
P59.0
ICD-10 code description
Neonatal jaundice associated with preterm delivery

Primary outcomes

1

Description
level of bilirubin
Timepoint
6hours/24hours/48hours
Method of measurement
mg/dl

2

Description
time of phototherapy
Timepoint
6hours/24hours/48hours
Method of measurement
hour

Secondary outcomes

empty

Intervention groups

1

Description
all of neonate will treat with photothrapy.neonate in sulfate group reciecive 1mg/kg (5mg/5cc)zincsulfate more than photo.prescription is oral with syrang and every 6 hours until the end of phototherapy.measurment of the level of bilirubin is the bigining of admission then 6 hours after that and then daily
Category
Treatment - Drugs

2

Description
In control group neonatewill recieve 1mg/kg placebo(sucrose) more than photo.prescription is oral with syrang and every 6 hours until the end of phototherapy.measurment of the level of bilirubin is the bigining of admission then 6 hours after that and then daily ,
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Hoda Khatib
Street address
City
Mashad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medica Sciences
Full name of responsible person
Reza Sharifzadeh
Street address
Ghafari aven
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medica 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
Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Faal
Position
Specialty in Neonate
Other areas of specialty/work
Street address
Valiasr Hospital
City
Birjand
Postal code
Phone
+98 56 3244 3005
Fax
Email
grfal@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Uciences
Full name of responsible person
Gholam Reza Faal
Position
specialty in neonate
Other areas of specialty/work
Street address
Ghafari aveniue
City
Birjand
Postal code
Phone
+98 56 3244 3005
Fax
Email
grfal@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Medicine Scinese
Full name of responsible person
Hoda Khatib Masjedi
Position
Pediatric resident
Other areas of specialty/work
Street address
Ghafari Avenue
City
Birjand
Postal code
Phone
+98 51 3604 3228
Fax
Email
hmkhatib2772@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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