NCT02814929

Brief Summary

The study includes preterm infants who are being screened for ROP between April 1,2016 and April 30, 2017 in 69 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or gestational age (GA) \>32 weeks with an unstable clinical course 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

87
On Track

Trial Health Score

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

Enrollment
6,115

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

June 14, 2016

Last Update Submit

September 7, 2023

Conditions

Retinopathy of Prematurity

Keywords

ROPRisk factorsIncidenceTurkey

Outcome Measures

Primary Outcomes (1)

  • Incidence of ROP in Turkey

    Incidence of ROP and severe ROP in relation to GA and BW in Turkey

    12 months

Secondary Outcomes (11)

  • The association of antenatal corticosteroid administration with ROP

    12 months

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

    12 months

  • The relationship between rate of postnatal weight gain and severity of ROP

    12 months

  • The relationship between breastfeeding and ROP development

    12 months

  • ROP in SGA premature infants

    12 months

  • +6 more secondary outcomes

Other Outcomes (1)

  • Incidence of ROP in preterm babies of refugees in Turkey

    12 months

Study Arms (3)

Demographic and Prenatal Characteristics

Gender, multiple pregnancy antenatal steroid therapy, invitro fertilisation, preeclampsia/eclampsia, infants of diabetic mother, chorioamnionitis will be compared among infants with and without ROP

Neonatal Characteristics of infants

Neonatal characteristics: GA, BW, SGA, resuscitation in delivery room, RDS, duration of mechanical ventilation and oxygen therapy, intracranial hemorrhage, hemodynamically significant PDA, early/late sepsis, NEC, number of blood transfusions, BPD, breastfeeding and weight gain at postnatal 28th day will be compared among infants with and without ROP.

Incidence of any ROP and severe ROP

Incidence of any ROP, severe ROP and its treatment in relation to BW and GA will be evaluated. The same parameters will also be evaluated in preterm babies of refugees.

Eligibility Criteria

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

Preterm babies screened for ROP.

You may qualify if:

  • Infants with BW ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or GA \>32 weeks requiring cardiorespiratory support and who were determined by the attending clinician to be at risk for ROP, are included.

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)

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Ankara, Keçi̇ören, 06100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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: 25868788RESULT

  • 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: 29519879DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahmet Y Bas, MD

    Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

    PRINCIPAL INVESTIGATOR

  • Nihal Demirel, MD

    Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

    PRINCIPAL INVESTIGATOR

  • İbrahim M Hirfanoglu, MD

    Gazi University

    PRINCIPAL INVESTIGATOR

  • Dilek U Isik, MD

    Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

    PRINCIPAL INVESTIGATOR

  • Turan Tunc, MD

    Istanbul

    PRINCIPAL INVESTIGATOR

  • Esin Koc, MD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 28, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 17, 2017

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)