1. Objective: The objective is to define the effectiveness of povidone iodine and erythromycin and find the most effective and economical method for prevention of ophthalmia neonatorum.
2. Design: In a masked randomized clinical trial 2100 neonates are randomly divided to three groups of Erythromycin (E), povidone iodine (P) and control groups. According to Iranian healthy newborn care service package, which is the guideline for Iranian pediatricians for newborn care, if mothers had no gonococcal or chlamydial infections, prophylaxis is not recommended for ophthalmia neonatorum. Mothers are educated about the signs of ophthalmia neonaturum. All cases will be visited on 3 occasions: After 24 hours, days 3-7 and days 7-10.
3. Setting and conduct: In a 2 month period in 2 major hospitals of Hafez and Zeynabieh in Shiraz.
4. Participants and eligibility criteria: All neonates with maternal consent and inclusion criteria and not having the following exclusion criteria: ocular malformations, antibiotic usage by mother in the last week of pregnancy, mothers can’t bring the neonate to hospital in case of conjunctivitis, and mothers with current gonococcal or chlamydial infection. each group has 700 enrollees (n=700); as a result, 2100 neonates will be studied.
5. Intervention: Subjects are randomly assigned to Erythromycin (E), povidone iodine (P) and control groups.
6. Main outcome: Presence or absence of ophthalmia neonatorum.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031717034N1
Registration date:2014-04-19, 1393/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Homeira Vafaei Cisakht
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
vafaeih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research deputy of Shiraz university of medical sciences, Infertility Research Center, Shiraz university of medical sciences.
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2014-07-07, 1393/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of topical povidone iodine (2.5%), and topical erythromycin in prevention of ophthalmia neonatorum, in Shiraz, in 2014
Public title
Povidone iodine and topical erythromycin in prevention of ophthalmia neonatorum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: mother's consent.
Exclusion criteria: Ocular malformations; Antibiotic usage by mother in the last week of pregnancy; Mothers can’t bring the neonate to hospital in case of conjunctivitis; Mothers with current gonococcal or chlamydial infection.
Age
To 1 month old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
2100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences ethics committee
Street address
Shiraz university of medical sciences, Zand blvd.
City
Shiraz
Postal code
Approval date
2014-02-23, 1392/12/04
Ethics committee reference number
CT-P-92-5107
Health conditions studied
1
Description of health condition studied
Neonatal chlamydial conjunctivitis and neonatal conjunctivitis NOS.
3 Occasions: After 24 hours, days 3-7 and days 7-10
Method of measurement
History and physical exam
Secondary outcomes
1
Description
Cultured microorganism
Timepoint
When conjunctivitis detected
Method of measurement
Culture
Intervention groups
1
Description
Neonates with no eye abnormalities or infection are divided to two groups. Group 1 receives topical erythromycin at the time of birth. At first 24 hours, 3-7 and 7-10 days later patients are visited for infection.
Category
Prevention
2
Description
Neonates with no eye abnormalities or infection are divided to two groups. Group 2 receives topical povidone iodine at the time of birth. At first 24 hours, 3-7 and 7-10 days later patients are visited for infection.
Category
Prevention
3
Description
Neonates with no eye abnormalities or infection are divided to two groups. Group 3 (control) receives distilled water at the time of birth. At first 24 hours, 3-7 and 7-10 days later patients are visited for infection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
dr Nasrin dadras
Street address
Chamran Blvd.
City
Shiraz
2
Recruitment center
Name of recruitment center
Hazrate Zeinab hospital
Full name of responsible person
dr Nasrin Dadras
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research of Shiraz university of medical sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
7th Floor dean of research, Shiraz university of medical sciences, Zand blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research of Shiraz 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
Shiraz university of medical sciences
Full name of responsible person
Hossein Haghbin
Position
Medical intern
Other areas of specialty/work
Street address
Shiraz university of medical sciences, Zand blvd.
City
Shiraz
Postal code
Phone
+98 71 1648 6731
Fax
Email
Hoshaq@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Homeira Vafaei Cisakht
Position
Assistant Professor, Felowship of perinatalogy
Other areas of specialty/work
Street address
Department of perinatalogy, Hafez hospital, Chamran blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
Vafaeih@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Khadije Bazrafshan
Position
Masters
Other areas of specialty/work
Street address
Shiraz university of medical sciences, Zand Blvd
City
shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
hafez_perina@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)