Diagnosis and complications of retinal vascular disease developing in preterm children
| ISRCTN | ISRCTN18040926 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18040926 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 7929783.v1 |
| Sponsor | Department of Ophthalmology, University of Health Sciences (SBU) Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Turkey |
| Funder | Absent |
- Submission date
- 15/07/2018
- Registration date
- 24/07/2018
- Last edited
- 06/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Babies born prematurely have a very low birth weight. In Turkey, 25,000 very low weight babies are born annually, with around 1000 of them facing the risk of blindness (retinopathy of prematurity (ROP)).
The likelihood of these babies developing ROP is affected by the treatment and follow-up that they receive, along with any complications. We retrospectively reviewed the treatment, follow-up period and treatment complications of 302 premature, low birth weight babies who were examined for ROP at SBÜ Bursa YİEAH ROP between the dates of February 2016 to February 2017, to determine the effects of treatment and complications of ROP and demonstrate that complete rehabilitation can be achieved with strict follow-up and appropriate treatment.
Who can participate?
Premature babies, born between 6 and 35 weeks of gestation
What does the study involve?
There is no direct participation for infants involved in the study. Instead, this is a retrospective review of the treatment, follow-up period and treatment complications of participants.
What are the possible benefits and risks of taking part?
The possible benefit of taking part is that it may help prevent severe vision loss in future premature babies. There are no known risks to participants taking part in this study.
Where is the study run from?
SBU Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Turkey
When is the study starting and how long is it expected to run for?
1st July 2018 to 15th July 2018
Who is funding the study?
1. Social Security Institution (Turkey)
2. SBU Bursa Yüksek İhtisas Training and Research Hospital (Turkey)
Who is the main contact?
1. Müberra Akdoğan (mbrakdogan@yahoo.com)
2. Görkem Çevik (gorkemcevic@hotmail.com)
Contact information
Scientific
Mursel Mah. Egitim Cad. 16. sok. Sevilla Villaları G1 villa no.1
Bursa
16110
Türkiye
 ORCID ID |
0000-0003-4846-312X |
|---|---|
| Phone | 05052408229 |
| mbrakdogan@yahoo.com |
Scientific
SBU Bursa Yüksek İhtisas Training and Research Hospital
Mimar Sinan Mah. Emniyet Cad. Polis Okulu Karşısı Yıldırım
Bursa
16310
Türkiye
| ORCID ID |
0000-0002-5653-5800 |
|---|---|
| Phone | +90 224 295 50 00 |
| gorkemcevik@hotmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional retrospective review |
| Secondary study design | Cross sectional study |
| Participant information sheet | ISRCTN18040926_PIS.docx |
| Scientific title | Diagnosis, treatment and complications of retinopathy of prematurity |
| Study acronym | ROP |
| Study objectives | To determine the effects of diagnosis, treatment and complications of retinopathy of prematurity and demonstrate that complete rehabilitation can be achieved with strict follow-up and appropriate treatment of severe ROP |
| Ethics approval(s) | SBU Bursa Higher Specialized Education Research Hospital, 01/07/2018, 31234050-514.10 |
| Health condition(s) or problem(s) studied | Retinopathy of prematurity |
| Intervention | Records were reviewed, using the International Classification of Retinopathy of Prematurity (ICROP) criteria to review diagnoses and the Early Treatment of Retinopathy of Prematurity (ETROP) study group criteria to review treatments. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
The following were measured from birth to the end of the follow-up period: |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 15/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 302 |
| Key inclusion criteria | Preterm babies born between 6 and 35 weeks of gestation |
| Key exclusion criteria | N/A |
| Date of first enrolment | 01/02/2016 |
| Date of final enrolment | 01/02/2017 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Mimarsinan Mahallesi, No:, Emniyet Cd. No:35, 16310 Yıldırım/Bursa
BURSA
16310
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Retinal images (if available) and clinical follow-up information without the patient's identity information can be obtained from mbrakdogan@yahoo.com. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/03/2015 | Yes | No | |
| Participant information sheet | 02/04/2019 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN18040926_PIS.docx
- Uploaded 02/04/2019
Editorial Notes
06/11/2019: Internal review.
02/04/2019: The participant information sheet has been uploaded.
