Diagnosis and complications of retinal vascular disease developing in preterm children

ISRCTN ISRCTN18040926
DOI https://doi.org/10.1186/ISRCTN18040926
Secondary identifying numbers 7929783.v1
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Mrs Müberra Akdoğan
Scientific

Mursel Mah. Egitim Cad. 16. sok. Sevilla Villaları G1 villa no.1
Bursa
16110
Türkiye

ORCiD logoORCID ID 0000-0003-4846-312X
Phone 05052408229
Email mbrakdogan@yahoo.com
Dr Sadık Görkem Çevik
Scientific

SBU Bursa Yüksek İhtisas Training and Research Hospital
Mimar Sinan Mah. Emniyet Cad. Polis Okulu Karşısı Yıldırım
Bursa
16310
Türkiye

ORCiD logoORCID ID 0000-0002-5653-5800
Phone +90 224 295 50 00
Email gorkemcevik@hotmail.com

Study information

Study designObservational cross sectional retrospective review
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeScreening
Participant information sheet ISRCTN18040926_PIS.docx
Scientific titleDiagnosis, treatment and complications of retinopathy of prematurity
Study acronymROP
Study objectivesTo 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) studiedRetinopathy of prematurity
InterventionRecords 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 typeMixed
Primary outcome measureThe following were measured from birth to the end of the follow-up period:
1. Total maturation of retinal vascularisation
2. IVB (intravitreal bevacizumab) dose
3. LPC (laser photocoagulation) treatment
4. Complications after treatment
5. Stage of ROP
6. Gender of infant
7. Follow-up duration (weeks)
8. Gestational week of birth
9. Incubation duration (days)
Secondary outcome measuresN/A
Overall study start date01/07/2018
Completion date15/07/2018

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participantsVarious ROP stages were observed in 118; no ROP was observed in 184. Infants with and without ROP
Key inclusion criteriaPreterm babies born between 6 and 35 weeks of gestation
Key exclusion criteriaN/A
Date of first enrolment01/02/2016
Date of final enrolment01/02/2017

Locations

Countries of recruitment

  • Türkiye

Study participating centre

Department of Ophthalmology, University of Health Sciences (SBU) Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Turkey
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Mimarsinan Mahallesi, No:, Emniyet Cd. No:35, 16310 Yıldırım/Bursa
BURSA
16310
Türkiye

Sponsor information

Department of Ophthalmology, University of Health Sciences (SBU) Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Turkey
Government

Mimar Sinan Mah. Emniyet Cad. Polis Okulu Karşısı
Bursa
16340
Türkiye

Phone +90 224 295 50 00
Email mbrakdogan@yahoo.com
Website bursaihtisas.saglik.gov.tr
ROR logo "ROR" https://ror.org/05nhkt138

Funders

Funder type

Not defined

Absent

No information available

Results and Publications

Intention to publish date02/08/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planRetinal 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

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.