The aim of this study was to evaluate the effect of Betadine 2.5% on prevention of neonatal conjunctivitis. Inclusion criteria will be included all healthy term and preterm neonates. Exclusion criteria will be included all neonates that need for resuscitation, special measures and neonates with congenital malformations of the eyes. The statistical population of this study will be included all neonates those will bear from September 23, 2017 to March 20, 2018 in Qazvin Kowsar Hospital. The sample number will be 200 neonates. In the first group, two drops of Betadine 2.5% (prophylaxis group) and the second group two drops of distilled sterile water (control group) will be shed in the conjunctiva of the eyes. Intervention will be only taken place on the first day of birth. The primary outcome variables will be included eye redness, purulent discharge and inflammation of conjunctive of eyes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022032680N1
Registration date:2017-08-13, 1396/05/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Fakhrosadat Hosseini Moghaddam Emami
Name of organization / entity
Qazvin university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8709
Email address
f.emami@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin university of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 2.5% betadine in the prevention of neonatal conjunctivitis
Public title
The effect of betadine drop in neonatal conjunctivitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All healthy term and preterm neonates
Exclusion criteria: All neonates that needs to resuscitation; special measures; neonates with congenital malformations of the eyes
Age
To 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of medical Sciences
Street address
Bahonar Blvd, Qazvin University of Medical Sciences, Qazvin
City
Qazvin
Postal code
59811-34197
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
IR.QUMS.REC.1395.280
Health conditions studied
1
Description of health condition studied
Neonatal Conjunctivitis
ICD-10 code
P39.1
ICD-10 code description
Neonatal conjunctivitis and dacryocystitis
Primary outcomes
1
Description
Conjunctivitis
Timepoint
22 May 2017-23 June 2017
Method of measurement
Visual
Secondary outcomes
1
Description
Drug sensitivity
Timepoint
48 hours and one week after treatment
Method of measurement
Visual
Intervention groups
1
Description
In the second group (control) two drops of distilled sterile water will be shed in the conjunctiva eyes
Category
Prevention
2
Description
In the first group (Intervention), two drops of Betadine 2.5% will be shed in the conjunctiva eyes
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital, Qazvin University of Medical Sciences
Full name of responsible person
Fakhrosadat Hosseini Moghaddam Emami
Street address
Kosar Hospital, Kosar Alley, Taleqani St., Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences, Qazvin
Full name of responsible person
Amir Peymani
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences, Qazvin
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
Qazvin University of Medical Sciences
Full name of responsible person
Fakhrosadat Hosseini Moghaddam Emami
Position
General practitioner
Other areas of specialty/work
Street address
Qazvn University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Fax
+98 28 3333 6002
Email
f.emami@qums.ac.ir
Web page address
http://www.qums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fakhrosadat Hosseini Moghaddam Emami
Position
General practitioner
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Fax
+98 28 3333 7006
Email
f.emami@qums.ac.ir
Web page address
http://www.qums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fakhrosadat Hosseini Moghaddam Emami
Position
General practitioner
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Postal code
4595-1-34159
Phone
+98 28 3333 6001
Fax
+98 28 3333 7006
Email
f.emami@qums.ac.ir
Web page address
http://www.qums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)