NCT06265363

Brief Summary

The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of \>1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

February 1, 2024

Last Update Submit

October 31, 2024

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

  • Incidence of ROP

    Incidence of ROP and severe ROP in infants \> 1500 gr and gestational age ≥ 33 weeks in Turkey.

    12 months

Secondary Outcomes (7)

  • The role of being SGA in infants in the development of ROP

    12 months

  • The role of sepsis in infants in the development of ROP

    12 months

  • The role of mechanical ventilation in infants in the development of ROP

    12 months

  • The role of chorioamnionitis in infants in the development of ROP

    12 months

  • Laser photocoagulation treatment

    12 months

  • +2 more secondary outcomes

Eligibility Criteria

Age28 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infants with BW \>1500 g or ≥33 weeks' gestation who were screened for ROP.

You may qualify if:

  • Infants with BW \>1500 g or ≥33 weeks' gestation who were determined to be at risk for ROP by the attending clinician and were screened for ROP.

You may not qualify if:

  • Neonates who died before the first ROP examination are excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Chiang MF, Quinn GE, Fielder AR, Ostmo SR, Paul Chan RV, Berrocal A, Binenbaum G, Blair M, Peter Campbell J, Capone A Jr, Chen Y, Dai S, Ells A, Fleck BW, Good WV, Elizabeth Hartnett M, Holmstrom G, Kusaka S, Kychenthal A, Lepore D, Lorenz B, Martinez-Castellanos MA, Ozdek S, Ademola-Popoola D, Reynolds JD, Shah PK, Shapiro M, Stahl A, Toth C, Vinekar A, Visser L, Wallace DK, Wu WC, Zhao P, Zin A. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68. doi: 10.1016/j.ophtha.2021.05.031. Epub 2021 Jul 8.

    PMID: 34247850BACKGROUND

  • Bas AY, Demirel N, Koc E, Ulubas Isik D, Hirfanoglu IM, Tunc T; TR-ROP Study Group. Incidence, risk factors and severity of retinopathy of prematurity in Turkey (TR-ROP study): a prospective, multicentre study in 69 neonatal intensive care units. Br J Ophthalmol. 2018 Dec;102(12):1711-1716. doi: 10.1136/bjophthalmol-2017-311789. Epub 2018 Mar 8.

    PMID: 29519879BACKGROUND

  • Bas AY, Koc E, Dilmen U; ROP Neonatal Study Group. Incidence and severity of retinopathy of prematurity in Turkey. Br J Ophthalmol. 2015 Oct;99(10):1311-4. doi: 10.1136/bjophthalmol-2014-306286. Epub 2015 Apr 13.

    PMID: 25868788BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Esin Koç, MD

    Gazi University

    STUDY DIRECTOR

  • Ahmet Y Bas, MD

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

  • İbrahim M Hirfanoğlu, MD, PhD

    Gazi University

    STUDY DIRECTOR

  • Sezin Unal, MD

    Baskent University

    STUDY DIRECTOR

Central Study Contacts

Sezin Unal

CONTACT

0090532sezinunal@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sezin Unal, MD

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 20, 2024

Study Start

August 1, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)