International Classification of Retinopathy of Prematurity, Third Edition.
Michael F Chiang, Graham E Quinn, Alistair R Fielder...
https://pubmed.ncbi.nlm.nih.gov/34247850Actively Recruiting
Age: 28Days +
All Genders
ID06265363
Evaluation of the Frequency of Retinopathy of Prematurity, Influencing Risk Factors, and Treatment Outcomes in Premature Infants With a Birth Weight >1500 Grams or Gestational Age ≥33 Weeks in Turkey
Led by Baskent University Ankara Hospital · Updated on 2024-11-01
1000
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
B
Baskent University Ankara Hospital
Lead Sponsor
H
Hacettepe University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying preterm infants in Turkey who are being screened for retinopathy of prematurity (ROP) between August 1, 2023, and August 1, 2024. The study focuses on infants with a birth weight over 1500 grams or gestational age of 33 weeks or more. It aims to determine how often ROP occurs, identify severe cases requiring treatment, and evaluate risk factors contributing to ROP development. Certified neonatologists from 94 neonatal intensive care units across Turkey collect data using electronic questionnaires. Medical records of retinal exams are reviewed, and detailed risk factors like gestational age, birth weight, steroid therapy, infections, respiratory issues, and feeding methods are recorded. The study also includes infants of refugees to assess ROP incidence within this group. Ophthalmologic exams continue until full retinal vascularization, with disease stages and treatments tracked according to international guidelines. Participants are monitored throughout their NICU stay with data pooled for analysis. Researchers assess the incidence of ROP, evaluate treatment outcomes such as laser photocoagulation and anti-VEGF therapy, and study the impact of various clinical factors on ROP development. The primary outcome is the incidence of ROP within 12 months, with secondary outcomes addressing specific risk factors and treatment methods.
CONDITIONS
Brief Title
Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey.
Who Can Participate
Age: 28Days +
All Genders
Eligibility Criteria
You may qualify if you...
- Infants with birth weight over 1500 grams or gestational age 33 weeks or more who are considered at risk for ROP and are being screened by their clinician
You will not qualify if you...
- Neonates who died before the first ROP eye examination are excluded from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits for retinal examinations
Diagnostic Evaluation
Duration - Up to 12 months until full vascularisation
Participants undergo ophthalmologic examinations using the International Classification of ROP guidelines to determine the stage and severity of retinopathy of prematurity.
Multiple retinal examination visits as clinically indicated until full vascularisation
Long-term Monitoring
Duration - Up to 12 months
Participants are monitored for outcomes including the incidence of ROP and treatment modalities such as laser photocoagulation, anti-VEGF, or vitreoretinal surgery as needed.
Follow-up visits depending on treatment and clinical need
Trial Site Locations
Total: 1 location
1
Baskent University
Ankara, Turkey (Türkiye)
Actively Recruiting
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Research Team
S
Sezin Unal
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Incidence, risk factors and severity of retinopathy of prematurity in Turkey (TR-ROP study): a prospective, multicentre study in 69 neonatal intensive care units.
Ahmet Yagmur Bas, Nihal Demirel, Esin Koc...
https://pubmed.ncbi.nlm.nih.gov/29519879Incidence and severity of retinopathy of prematurity in Turkey.
Ahmet Yagmur Bas, Esin Koc, Ugur Dilmen...
https://pubmed.ncbi.nlm.nih.gov/25868788