Retinopathy of Prematurity:Summary of a Decade

Retinopathy of Prematurity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363960
• Other study ID #: Retinopathy of prematurity
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: May 31, 2011
• Start date: March 1999
• Est. completion date: December 2010

Study information

• Verified date: June 2009
• Source: Gulhane Military Medical Academy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey:Gulhane Military Medical School Local Ethical Committee
• Study type: Observational

Clinical Trial Summary

The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Neonates either with a BW of less than 1501 gram (g) or born at a GA of 34 weeks (wk) or less

• selected infants with an unstable clinical course were included

Study Design

N/A

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Locations

Country	Name	City	State
Turkey	Gulhane Military Medical School Training Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Military Medical Academy

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of neonates developed retinopathy of prematurity		ten years	No
Primary	risk factors contributing to ROP development	mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s	ten years	No

External Links

•   retinopathy of prematurity