Plain English Summary
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)
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Müberra Akdoğan
ORCID ID
http://orcid.org/0000-0003-4846-312X
Contact details
Mursel Mah. Egitim Cad. 16. sok. Sevilla Villaları G1 villa no.1
Bursa
16110
Turkey
05052408229
mbrakdogan@yahoo.com
Type
Scientific
Additional contact
Dr Sadık Görkem Çevik
ORCID ID
http://orcid.org/0000-0002-5653-5800
Contact details
SBU Bursa Yüksek İhtisas Training and Research Hospital
Mimar Sinan Mah. Emniyet Cad. Polis Okulu Karşısı Yıldırım
Bursa
16310
Turkey
+90 224 295 50 00
gorkemcevik@hotmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
7929783.v1
Study information
Scientific title
Diagnosis, treatment and complications of retinopathy of prematurity
Acronym
ROP
Study hypothesis
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
SBU Bursa Higher Specialized Education Research Hospital, 01/07/2018, 31234050-514.10
Study design
Observational cross sectional retrospective review
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
See additional files
Condition
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
Phase
Drug names
Primary outcome measure
The 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 measures
N/A
Overall trial start date
01/07/2018
Overall trial end date
15/07/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Preterm babies born between 6 and 35 weeks of gestation
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Various ROP stages were observed in 118; no ROP was observed in 184. Infants with and without ROP
Participant exclusion criteria
N/A
Recruitment start date
01/02/2016
Recruitment end date
01/02/2017
Locations
Countries of recruitment
Turkey
Trial 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
Turkey
Sponsor information
Organisation
Department of Ophthalmology, University of Health Sciences (SBU) Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Turkey
Sponsor details
Mimar Sinan Mah. Emniyet Cad. Polis Okulu Karşısı
Bursa
16340
Turkey
+90 224 295 50 00
mbrakdogan@yahoo.com
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
Absent
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
Retinal images (if available) and clinical follow-up information without the patient's identity information can be obtained from mbrakdogan@yahoo.com.
Intention to publish date
02/08/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: https://www.researchgate.net/publication/273324460_Relationship_between_mean_platelet_volume_and_retinopathy_of_prematurity
Publication citations
Additional files
- ISRCTN18040926_PIS.docx Uploaded 02/04/2019