Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey (TR-ROP)

September 7, 2023 updated by: Ahmet Yagmur BAS, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey: A Prospective Multicenter Study Including 69 NICUs

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study, promoted by the "Turkish Neonatology Society", involved preterm infants who are being screened for ROP between April 1, 2016 and April 30, 2017 in level III Turkish NICUs.

An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network. Neonatologists working in 69 centers who agreed to participate in this study provide their data regarding the ROP in their NICU. The medical records of retinal examinations of preterm infants who met the screening criteria will be evaluated.

A case report form for each patient will be filled including risk factors for the development of ROP such as gestational age, birth weight, small for gestational age (SGA), gender, multiple gestation, antenatal steroid therapy, invitro fertilisation, preeclampsia/eclampsia, infants of diabetic mother, chorioamnionitis, resuscitation in delivery room, respiratory distress syndrome (RDS), duration of mechanical ventilation and oxygen therapy, intracranial hemorrhage, hemodynamically significant patent ductus arteriosus (PDA), early/late sepsis, necrotising enterocolitis (NEC), number of blood transfusions, bronchopulmonary dysplasia (BPD), weight gain at postnatal 28th days and breastfeeding.

Risk factors for developing ROP will be evaluated. Multivariate analysis will be performed among significant variables.

In addition, the incidence of any ROP, severe ROP in relation to GA and BW and treatment modalities will be determined. Severe ROP is defined as ROP requiring treatment.

Since Turkey is receiving many refugees in recent years, the investigators also planned to evaluate the incidence and risk factors for developing ROP in preterm babies of refugees.

Ophthalmologic examination is continued until full vascularisation. So, the maximum stage of ROP detected for every infant will be reported. Data from 69 NICUs will be pooled together and analyzed.

The "International Classification of ROP" guidelines are used to record stage of disease, location by zone, signs of plus disease and signs of regression. Criteria for treatment of ROP are based on the Early Treatment for Retinopathy of Prematurity (ETROP) recommendation. Confirmed forms are also assigned by the parents before the initial screening and treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Keçi̇ören
      • Ankara, Keçi̇ören, Turkey, 06100
        • Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 weeks and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Preterm babies screened for ROP.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of ROP in Turkey
Time Frame: 12 months
Incidence of ROP and severe ROP in relation to GA and BW in Turkey
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The association of antenatal corticosteroid administration with ROP
Time Frame: 12 months
12 months
The role of sepsis in infants in the development of ROP
Time Frame: 12 months
Culture proven and clinical early and late sepsis will be evaluated
12 months
The relationship between rate of postnatal weight gain and severity of ROP
Time Frame: 12 months
12 months
The relationship between breastfeeding and ROP development
Time Frame: 12 months
12 months
ROP in SGA premature infants
Time Frame: 12 months
Comparison of ROP in SGA infants with those of appropriate size for GA
12 months
ROP in multiple births
Time Frame: 12 months
Comparison of the frequency and severity of ROP among singleton and multiple-birth neonates
12 months
The role of transfusions in ROP development
Time Frame: 12 months
12 months
Duration of oxygen therapy among infants with and without ROP
Time Frame: 12 months
12 months
Number of patients requiring laser photocoagulation treatment
Time Frame: 12 months
12 months
Number of patients requiring vitreoretinal surgery
Time Frame: 12 months
12 months
Number of patients requiring anti-vascular endothelial growth factor treatment
Time Frame: 12 months
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of ROP in preterm babies of refugees in Turkey
Time Frame: 12 months
Incidence of any ROP and severe ROP in relation to GA and BW in preterm babies of refugees
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pamukkale University
Hacettepe University
Cukurova University
Kanuni Sultan Suleyman Training and Research Hospital
Baskent University
Marmara University
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Ataturk University
Bezmialem Vakif University
Muğla Sıtkı Koçman University
Yuzuncu Yıl University
Istanbul University
Bulent Ecevit University
Mustafa Kemal University
Selcuk University
Koç University
TC Erciyes University
Ege University
Dokuz Eylul University
Inonu University
Kahramanmaras Sutcu Imam University
Sisli Hamidiye Etfal Training and Research Hospital
Tokat Gaziosmanpasa University
Necmettin Erbakan University
Firat University
Ondokuz Mayıs University
Istanbul Medeniyet University
Zekai Tahir Burak Women's Health Research and Education Hospital
Bagcilar Training and Research Hospital
Tepecik Training and Research Hospital
Istanbul Medipol University Hospital
Uludag University
University of Gaziantep
Eskisehir Osmangazi University
Ankara University
Trakya University
Aydin Adnan Menderes University
Kırıkkale University
Karadeniz Technical University
Baskent University Ankara Hospital
Konya Meram State Hospital
Umraniye Education and Research Hospital
Kecioren Education and Training Hospital
Medical Park Gaziantep Hospital
Cengiz Gokcek Women's and Children's Hospital
Adana Numune Training and Research Hospital
Trabzon Kanuni Education and Research Hospital
Yuksek Ihtisas University
Suleymaniye Birth And Women's Health Education And Research Hospital
Dr. Behcet Uz Children's Hospital
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Dicle University
Acibadem Atakent University Hospital
NCR International Hospital
Ankara Guven Hospital
Ataşehir Kadıkoy Sifa Hospital
Dortcelik Children Hospital
Canakkale 18 Mart University
Denizli Devlet Hastanesi
Denizli Ozel Saglik Hospital
Doruk Bursa Hospital
Faruk Sukan Maternity and Children Hospital
Erzurum Nenehatun Maternity Hospital
Kahramanmaras Megapark Hospital
Konya Baskent University
Mersin Maternity Hospital
Ozel Medova Hospital
Sami Ulus Maternity and Children Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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, İstanbul
  • Principal Investigator: Esin Koc, MD, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Turkey ROP Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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