Retinopathy of PrematurityNCT01363960
Retinopathy of Prematurity:Summary of a Decade
An observational study of Retinopathy of Prematurity, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity
- How many people
- 609 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 1999to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: neonates with Retinopathy of of prematurity
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Military Medical School Training Hospital
Ankara, 06010
About this study
The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening.
- Conditions
- Retinopathy of Prematurity
- Keywords
- Incidence, neonatal care, retinopathy of prematurity, risk factors
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neonates developed retinopathy of prematurity
Measured: ten years
risk factors contributing to ROP development
mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startMar 1999
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363960
- Sponsor's protocol ID
- Retinopathy of prematurity
- Status last verified
- Jun 2009
- First submitted
- 27 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinopathy of Prematurity:Summary of a Decade
- ClinicalTrials.gov ID
- NCT01363960
- Acronym / sponsor ID
- Retinopathy of prematurity
- Conditions
- Retinopathy of Prematurity
- Keywords
- Incidence, neonatal care, retinopathy of prematurity, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Mar 1999
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- neonates with Retinopathy of of prematurity
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of neonates developed retinopathy of prematurity
Time frame: ten years
risk factors contributing to ROP development
Time frame: ten years
mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
- Related InfoLink provided by the sponsor.
- retinopathy of prematurityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonates developed retinopathy of prematurity (time frame: ten years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.