NCT01363960

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
609

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
Last Updated

June 2, 2011

Status Verified

June 1, 2009

Enrollment Period

11.8 years

First QC Date

May 27, 2011

Last Update Submit

May 31, 2011

Conditions

Retinopathy of Prematurity

Keywords

Incidenceneonatal careretinopathy of prematurityrisk factors

Outcome Measures

Primary Outcomes (2)

  • Number of neonates developed retinopathy of prematurity

    ten years

  • risk factors contributing to ROP development

    mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s

    ten years

Study Arms (1)

neonates with retinopathy of prematurity

all neonates meet the criteria: 1. a BW of less than 1501 gram (g) 2. born at a GA of 34 weeks (wk) or less and 3. selected infants with an unstable clinical course were included

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

neonates with Retinopathy of of prematurity

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Military Medical School Training Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 2, 2011

Study Start

March 1, 1999

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 2, 2011

Record last verified: 2009-06

Locations

TU(1)