Retinopathy of PrematurityTR-ROP-2NCT06265363
Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey.
An observational study of Retinopathy of Prematurity, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Retinopathy of Prematurity
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants with BW >1500 g or ≥33 weeks' gestation who were screened for ROP.
Who may be able to join
- 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.
Who cannot join
- Neonates who died before the first ROP examination are excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University
Ankara
Sezin Unal, 0090532, sezinunal@gmail.com
Esin Koc, Prof
About this study
Official title: 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.
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.
Read the detailed description
This study, promoted by the "Turkish Neonatology Society", involved preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in level III/IV Turkish NICUs.
An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network. Neonatologists working in 94 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 fertilization, 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), time to full enteral feeding, percentage of own mothers milk.
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 94 NICUs will be pooled together and analyzed.
The "International Classification of ROP" guidelines (ICROP-3) are used to record the stage of disease, location by zone, signs of plus disease and signs of regression/reactivation/persistent avascular retina.
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.
- Conditions
- Retinopathy of Prematurity
- Medical subject headings
- Retinopathy of Prematurity
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ROP
Incidence of ROP and severe ROP in infants > 1500 gr and gestational age ≥ 33 weeks in Turkey.
Measured: 12 months
Secondary outcomes (7)
The role of being SGA in infants in the development of ROP
Number of infants with less than 10th percentile of birth weight according to Fenton graphs
Measured: 12 months
The role of sepsis in infants in the development of ROP
Number of infants diagnosed with early sepsis (< 3 days postnatal) or late sepsis (>3 days postnatal) during the NICU admission
Measured: 12 months
The role of mechanical ventilation in infants in the development of ROP
Duration of invasive mechanical ventilation during NICU admission
Measured: 12 months
The role of chorioamnionitis in infants in the development of ROP
The number of infants whose mothers with clinical/histological chorioamnionitis
Measured: 12 months
Laser photocoagulation treatment
Number of patients requiring laser photocoagulation treatment
Measured: 12 months
Anti-VEGF treatment
Number of patients requiring anti-VEGF treatment
Measured: 12 months
Vitreoretinal surgery
Number of patients requiring vitreoretinal surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Aug 2023
- Primary completion1 Sep 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Gazi University, Gaziosmanpasa Research and Education Hospital, Manisa Celal Bayar University, Selcuk University, Recep Tayyip Erdogan University, Karadeniz Technical University, Istinye University, Biruni University, Ordu University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Pamukkale University, Kanuni Sultan Suleyman Training and Research Hospital, Konya City Hospital, Kecioren Education and Training Hospital, Ataturk University, Meda Hospital, Eskisehir Osmangazi University, Necmettin Erbakan University, Kırıkkale University, Sisli Hamidiye Etfal Training and Research Hospital, Acibadem Atakent University Hospital, Balikesir Ataturk City Hospital, Kocaeli University, Acibadem Maslak Hospital, Erzurum City Hospital, Afyon Karahisar Hospital, Ankara Koru Hospital, Gulhane School of Medicine, Bursa Yuksek Ihtisas Training and Research Hospital, Namik Kemal University, Bursa City Hospital, Kayseri City Hospital, Ankara Etlik City Hospital, Zonguldak Bulent Ecevit University, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, Inonu University, Dr. Behcet Uz Children's Hospital, Ankara Training and Research Hospital, Tepecik Training and Research Hospital, Aydin Adnan Menderes University, Dicle University, Akdeniz University, Umraniye Education and Research Hospital, Ankara City Hospital Bilkent, Afyonkarahisar University of Health Sciences Health Application and Research Center, Harran University, Sanliurfa Mehmet Akif Inan Education and Research Hospital, Istanbul University - Cerrahpasa, Uludag University, Sanliurfa Education and Research Hospital, Dokuz Eylul University, Bursa Doruk Yıldırım Hospital, Malatya Turgut Ozal University, Abant Izzet Baysal University, Alanya Training and Research Hospital, İstanbul Training and Research Hospital, Baskent University, Kahramanmaras Sutcu Imam University, Batman Training and Research Hospital, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital, Acıbadem Atunizade Hospital, Adiyaman Training and Research Hospital, Zeynep Kamil Maternity and Pediatric Research and Training Hospital, Ondokuz Mayıs University, Trakya University, Trabzon Kanuni Education and Research Hospital, Seyhan Hospital, Esenyurt University Hospital, Başakşehir Çam & Sakura City Hospital, Sakarya University, Mardin Training and Research Hospital, Karabuk University, Giresun Training and Research Hospital, Koc University Hospital, Tekirdağ City Hospital, Istanbul Medipol University Hospital, Adana City Training and Research Hospital, Istanbul University, Marmara University Pendik Training and Research Hospital, Medikal Park Ankara Hospital, Muğla Sıtkı Koçman University, Yuzuncu Yil University, Sanko University, Antalya Training and Research Hospital, Firat University, Ankara Guven Hospital, Private Batman Hospital, İstanbul Bağcılar Training and Research Hospital, Istanbul Aydın University, Mersin City Hospital
- Responsible party
- Principal investigator, Sezin Unal, Baskent University Ankara Hospital
- Investigators
- Esin Koç, MD, Study director, Gazi UniversityAhmet Y Bas, MD, Study director, Ankara Yildirim Beyazıt Universityİbrahim M Hirfanoğlu, MD, PhD, Study director, Gazi UniversitySezin Unal, MD, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265363
- Sponsor's protocol ID
- TR-ROP-2 Study
- Acronym
- TR-ROP-2
- Status last verified
- Oct 2024
- First submitted
- 1 Feb 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34247850Bas 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.
PubMed 29519879Bas 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.
PubMed 25868788
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06265363
- Acronym / sponsor ID
- TR-ROP-2 / TR-ROP-2 Study
- Conditions
- Retinopathy of Prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Collaborators
- Hacettepe University, Gazi University, Gaziosmanpasa Research and Education Hospital, Manisa Celal Bayar University, Selcuk University, Recep Tayyip Erdogan University, Karadeniz Technical University, Istinye University, Biruni University, Ordu University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Pamukkale University, Kanuni Sultan Suleyman Training and Research Hospital, Konya City Hospital, Kecioren Education and Training Hospital, Ataturk University, Meda Hospital, Eskisehir Osmangazi University, Necmettin Erbakan University, Kırıkkale University, Sisli Hamidiye Etfal Training and Research Hospital, Acibadem Atakent University Hospital, Balikesir Ataturk City Hospital, Kocaeli University, Acibadem Maslak Hospital, Erzurum City Hospital, Afyon Karahisar Hospital, Ankara Koru Hospital, Gulhane School of Medicine, Bursa Yuksek Ihtisas Training and Research Hospital, Namik Kemal University, Bursa City Hospital, Kayseri City Hospital, Ankara Etlik City Hospital, Zonguldak Bulent Ecevit University, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, Inonu University, Dr. Behcet Uz Children's Hospital, Ankara Training and Research Hospital, Tepecik Training and Research Hospital, Aydin Adnan Menderes University, Dicle University, Akdeniz University, Umraniye Education and Research Hospital, Ankara City Hospital Bilkent, Afyonkarahisar University of Health Sciences Health Application and Research Center, Harran University, Sanliurfa Mehmet Akif Inan Education and Research Hospital, Istanbul University - Cerrahpasa, Uludag University, Sanliurfa Education and Research Hospital, Dokuz Eylul University, Bursa Doruk Yıldırım Hospital, Malatya Turgut Ozal University, Abant Izzet Baysal University, Alanya Training and Research Hospital, İstanbul Training and Research Hospital, Baskent University, Kahramanmaras Sutcu Imam University, Batman Training and Research Hospital, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital, Acıbadem Atunizade Hospital, Adiyaman Training and Research Hospital, Zeynep Kamil Maternity and Pediatric Research and Training Hospital, Ondokuz Mayıs University, Trakya University, Trabzon Kanuni Education and Research Hospital, Seyhan Hospital, Esenyurt University Hospital, Başakşehir Çam & Sakura City Hospital, Sakarya University, Mardin Training and Research Hospital, Karabuk University, Giresun Training and Research Hospital, Koc University Hospital, Tekirdağ City Hospital, Istanbul Medipol University Hospital, Adana City Training and Research Hospital, Istanbul University, Marmara University Pendik Training and Research Hospital, Medikal Park Ankara Hospital, Muğla Sıtkı Koçman University, Yuzuncu Yil University, Sanko University, Antalya Training and Research Hospital, Firat University, Ankara Guven Hospital, Private Batman Hospital, İstanbul Bağcılar Training and Research Hospital, Istanbul Aydın University, Mersin City Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study, promoted by the "Turkish Neonatology Society", involved preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in level III/IV Turkish NICUs.
An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network. Neonatologists working in 94 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 fertilization, 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), time to full enteral feeding, percentage of own mothers milk.
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 94 NICUs will be pooled together and analyzed.
The "International Classification of ROP" guidelines (ICROP-3) are used to record the stage of disease, location by zone, signs of plus disease and signs of regression/reactivation/persistent avascular retina.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants with BW >1500 g or ≥33 weeks' gestation who were screened for ROP.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Neonates who died before the first ROP examination are excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of ROP
Time frame: 12 months
Incidence of ROP and severe ROP in infants > 1500 gr and gestational age ≥ 33 weeks in Turkey.
7 secondary outcomes
The role of being SGA in infants in the development of ROP
Time frame: 12 months
The role of sepsis in infants in the development of ROP
Time frame: 12 months
The role of mechanical ventilation in infants in the development of ROP
Time frame: 12 months
The role of chorioamnionitis in infants in the development of ROP
Time frame: 12 months
Laser photocoagulation treatment
Time frame: 12 months
Anti-VEGF treatment
Time frame: 12 months
Vitreoretinal surgery
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Results publication: PubMed 34247850Chiang 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.
- Results publication: PubMed 29519879Bas 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.
- Results publication: PubMed 25868788Bas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esin Koç, MD study director
Gazi University
Ahmet Y Bas, MD study director
Ankara Yildirim Beyazıt University
İbrahim M Hirfanoğlu, MD, PhD study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sezin Unal (0090532, sezinunal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ROP (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265363, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.