Protocol summary

Summary
Aim: Comparison, effect of ophthalmic ointment tetracycline1% and erythromycin 0.5% in prophylaxis of ophthalmia Neonatorum. Type of Study: Monocenteric Single blind random controlled clinical trial without placebo The study group included neonates that born in Sanandaj Besat Hospital from march 2010 to march 2011. They were born both normal vaginal delivery and cesarean section. Inclusion criteria was normal neonates without congenital ophthalmic anomalies whom their mother had not received any antibiotics 48 hours before delivery and had not history of PROM (during 18 hrs to delivery) and meconium aspiration. Method: 330 neonates divided in 3 equal groups, 1 hour after birth after primary care and breast milk feeding. In group A one cm of ophthalmic ointment Tetracycline 1% and in group B one cm of ophthalmic ointment Erythromycin 0.5% was applied in both eyes. Group C was the control without medication. Questionnaire has 2 parts. The first part filled by nurse or Pediatrics Resident in the post partum ward. Before discharge the signs of conjunctivitis like redness, eye swelling and purulent discharge discussed for mothers and recommended them to come back on end of first and second and 4th weeks of birth every day. They was visited in OPD of Besat hospital. If they didn't come, we contacted them by telephone. If the infant had the any symptoms of conjunctivitis they was visited urgently and the second part of questionnaire including type of eye in comfort was filled.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101295714N1
Registration date: 2011-02-27, 1389/12/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-02-27, 1389/12/08
Registrant information
Name
Mohammad Hossein Kalantar
Name of organization / entity
Kurdistan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 87 1328 5910
Email address
kalantar.hossein@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kordestan University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial: Comparison, effect of Ophthalmic ointment tetracycline1% and erythromycin 0.5% in prophylaxis of ophthalmia Neonatorum.
Public title
Comparison, effect of Ophthalmic ointment tetracycline1% and erythromycin 0.5% in prophylaxis of ophthalmia Neonatorum.
Purpose
Prevention
Inclusion/Exclusion criteria
The study group included neonates that born in Sanandaj Besat Hospital from march 2010 to march 2011. They were born both normal vaginal delivery and cesarean section. An inclusion criterion was neonates born in Besat hospital. Exclusion criteria was congenital ophthalmic anomalies; receiving any antibiotics 48 hours before delivery; history of PROM (during 18 hrs to delivery); and mecunium aspiration
Age
To 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 330
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
Kurdistan University of Medical Science Ethics Commitee
Street address
Kurdistan University of Medical Science, Pasdaran AV., sanandaj
City
Sanandaj
Postal code
6618634683
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
82226

Health conditions studied

1

Description of health condition studied
neonatal conjunctivitis
ICD-10 code
P39.1
ICD-10 code description
Neonatal conjunctivitis

2

Description of health condition studied
Gonococcal conjunctivitis
ICD-10 code
A54.3
ICD-10 code description
Gonococcal infection of eye

Primary outcomes

1

Description
neonatal conjunctivitis
Timepoint
before intervention, 1 week, 2 weeks and 4 weeks later
Method of measurement
clinical examination

Secondary outcomes

1

Description
allergic reaction
Timepoint
1, 2, and 4 weeks after intervention
Method of measurement
clinical examination

Intervention groups

1

Description
330 neonates divided in 3 equal groups. In group A one cm of ophthalmic ointment Tetracyclin 1% was applied in both eyes just one time 1 hour after birth.
Category
Prevention

2

Description
In group B one cm of ophthalmic ointment Erythromycin 0.5% was applied in both eyes just one time 1 hour after birth.
Category
Treatment - Drugs

3

Description
Group C was the control without medication.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Mohammad Hossein Kalantar
Street address
Besat Hospital, Keshavarz Av., Sanandaj
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Medical Sciences Vice chancellor for research, Kordistan
Full name of responsible person
Ataollah Heidari
Street address
Medical University of Kordistan Vice Chancellor for Research, Pasdaran Av., Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Vice chancellor for research, Kordistan
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
Kurdistan University of Medical Science
Full name of responsible person
Mohammad Hossein Kalantar
Position
Doctor/ Pediatrics Resident
Other areas of specialty/work
Street address
Besat Hospital, Kurdistan Av., Sanandaj
City
Sanandaj
Postal code
6619667761
Phone
+98 87 1328 5910
Fax
+98 87 1328 5890
Email
kalantar.hossein@muk.ac.ir
Web page address
muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Science
Full name of responsible person
Nahid Ghotbi
Position
Professor
Other areas of specialty/work
Street address
Besat Hospital, Kurdistan Av., Sanandaj
City
Sanandaj
Postal code
6619667761
Phone
+98 87 1328 5910
Fax
+98 87 1328 5890
Email
ghotbinahid@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Science
Full name of responsible person
Mohammad Hossein Kalantar
Position
Doctor/ Pediatrics resident
Other areas of specialty/work
Street address
Besat Hospital, Kurdistan Av., Sanandaj
City
Sanandaj
Postal code
6619667761
Phone
+98 87 1328 5910
Fax
+98 87 1328 5890
Email
kalantar.hossein@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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