Back to resultsRetinopathy of Prematurity:Summary of a Decade
Primary Purpose
Retinopathy of Prematurity
Status
Completed
Phase
Locations
Turkey
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Retinopathy of Prematurity focused on measuring Incidence, neonatal care, retinopathy of prematurity, risk factors
Eligibility Criteria
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
Sites / Locations
- Gulhane Military Medical School Training Hospital
Arms of the Study
Arm 1
Arm Type
Arm Label
neonates with retinopathy of prematurity
Arm Description
all neonates meet the criteria: a BW of less than 1501 gram (g) born at a GA of 34 weeks (wk) or less and selected infants with an unstable clinical course were included
Outcomes
Primary Outcome Measures
Number of neonates developed retinopathy of prematurity
risk factors contributing to ROP development
mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s
Secondary Outcome Measures
Full Information
NCT ID
NCT01363960
First Posted
May 27, 2011
Last Updated
May 31, 2011
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
1. Study Identification
Unique Protocol Identification Number
NCT01363960
Brief Title
Retinopathy of Prematurity:Summary of a Decade
Study Type
Observational
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
Incidence, neonatal care, retinopathy of prematurity, risk factors
7. Study Design
Enrollment
609 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neonates with retinopathy of prematurity
Arm Description
all neonates meet the criteria:
a BW of less than 1501 gram (g)
born at a GA of 34 weeks (wk) or less and
selected infants with an unstable clinical course were included
Primary Outcome Measure Information:
Title
Number of neonates developed retinopathy of prematurity
Time Frame
ten years
Title
risk factors contributing to ROP development
Description
mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s
Time Frame
ten years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
neonates with Retinopathy of of prematurity
Sampling Method
Probability Sample
Facility Information:
Facility Name
Gulhane Military Medical School Training Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
retinopathy of prematurity
Learn more about this trial
Retinopathy of Prematurity:Summary of a Decade
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