Retinopathy of PrematurityTR-ROPNCT02814929
Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey
An observational study of Retinopathy of Prematurity, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… 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
- 6,115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2016to 17 Oct 2017
- 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: Preterm babies screened for ROP.
Who may be able to join
- 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.
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
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Ankara, Keçi̇ören, 06100
About this study
Official title: 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.
Read the 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.
- Conditions
- Retinopathy of Prematurity
- Keywords
- ROP, Risk factors, Incidence, Turkey
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ROP in Turkey
Incidence of ROP and severe ROP in relation to GA and BW in Turkey
Measured: 12 months
Secondary outcomes (11)
The association of antenatal corticosteroid administration with ROP
Measured: 12 months
The role of sepsis in infants in the development of ROP
Culture proven and clinical early and late sepsis will be evaluated
Measured: 12 months
The relationship between rate of postnatal weight gain and severity of ROP
Measured: 12 months
The relationship between breastfeeding and ROP development
Measured: 12 months
ROP in SGA premature infants
Comparison of ROP in SGA infants with those of appropriate size for GA
Measured: 12 months
ROP in multiple births
Comparison of the frequency and severity of ROP among singleton and multiple-birth neonates
Measured: 12 months
The role of transfusions in ROP development
Measured: 12 months
Duration of oxygen therapy among infants with and without ROP
Measured: 12 months
Number of patients requiring laser photocoagulation treatment
Measured: 12 months
Number of patients requiring vitreoretinal surgery
Measured: 12 months
Number of patients requiring anti-vascular endothelial growth factor treatment
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 posted28 Jun 2016 (estimated)
- Study start1 Apr 2016
- Primary completion1 Aug 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 6,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem Atakent University Hospital, Baskent University, Adana Numune Training and Research Hospital, Aydin Adnan Menderes University, Ankara University, Baskent University Ankara Hospital, Ankara Guven Hospital, Ataşehir Kadıkoy Sifa Hospital, Ataturk University, Bagcilar Training and Research Hospital, Bezmialem Vakif University, Dortcelik Children Hospital, Uludag University, Bulent Ecevit University, Canakkale 18 Mart University, Cukurova University, Denizli Devlet Hastanesi, Denizli Ozel Saglik Hospital, Dicle University, Dokuz Eylul University, Doruk Bursa Hospital, Faruk Sukan Maternity and Children Hospital, Ege University, Erzurum Nenehatun Maternity Hospital, Eskisehir Osmangazi University, Firat University, Cengiz Gokcek Women's and Children's Hospital, University of Gaziantep, Mustafa Kemal University, Hacettepe University, Istanbul Medeniyet University, Istanbul Medipol University Hospital, Istanbul University, Dr. Behcet Uz Children's Hospital, Kahramanmaras Megapark Hospital, Kahramanmaras Sutcu Imam University, Kanuni Sultan Suleyman Training and Research Hospital, Karadeniz Technical University, TC Erciyes University, Kecioren Education and Training Hospital, Kırıkkale University, Konya Baskent University, Konya Meram State Hospital, Selcuk University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Marmara University, Medical Park Gaziantep Hospital, Mersin Maternity Hospital, NCR International Hospital, Necmettin Erbakan University, Ozel Medova Hospital, Pamukkale University, Umraniye Education and Research Hospital, Inonu University, Sami Ulus Maternity and Children Hospital, Ondokuz Mayıs University, Suleymaniye Birth And Women's Health Education And Research Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Tepecik Training and Research Hospital, Tokat Gaziosmanpasa University, Trabzon Kanuni Education and Research Hospital, Trakya University, Yuksek Ihtisas University, Yuzuncu Yil University, Zekai Tahir Burak Women's Health Research and Education Hospital, Zeynep Kamil Maternity and Pediatric Research and Training Hospital, Muğla Sıtkı Koçman University, Koç University
- Responsible party
- Principal investigator, Ahmet Yagmur BAS, Ankara Yildirim Beyazıt University
- Investigators
- Ahmet Y Bas, MD, Principal investigator, Etlik Zubeyde Hanim Womens' Health and Teaching HospitalNihal Demirel, MD, Principal investigator, Etlik Zubeyde Hanim Womens' Health and Teaching Hospitalİbrahim M Hirfanoglu, MD, Principal investigator, Gazi UniversityDilek U Isik, MD, Principal investigator, Etlik Zubeyde Hanim Womens' Health and Teaching HospitalTuran Tunc, MD, Principal investigator, IstanbulEsin Koc, MD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814929
- Sponsor's protocol ID
- Turkey ROP Study
- Acronym
- TR-ROP
- Status last verified
- Sep 2023
- First submitted
- 14 Jun 2016
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25868788Bas 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 29519879
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey: A Prospective Multicenter Study Including 69 NICUs
- ClinicalTrials.gov ID
- NCT02814929
- Acronym / sponsor ID
- TR-ROP / Turkey ROP Study
- Conditions
- Retinopathy of Prematurity
- Keywords
- ROP, Risk factors, Incidence, Turkey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,115 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Collaborators
- Acibadem Atakent University Hospital, Baskent University, Adana Numune Training and Research Hospital, Aydin Adnan Menderes University, Ankara University, Baskent University Ankara Hospital, Ankara Guven Hospital, Ataşehir Kadıkoy Sifa Hospital, Ataturk University, Bagcilar Training and Research Hospital, Bezmialem Vakif University, Dortcelik Children Hospital, Uludag University, Bulent Ecevit University, Canakkale 18 Mart University, Cukurova University, Denizli Devlet Hastanesi, Denizli Ozel Saglik Hospital, Dicle University, Dokuz Eylul University, Doruk Bursa Hospital, Faruk Sukan Maternity and Children Hospital, Ege University, Erzurum Nenehatun Maternity Hospital, Eskisehir Osmangazi University, Firat University, Cengiz Gokcek Women's and Children's Hospital, University of Gaziantep, Mustafa Kemal University, Hacettepe University, Istanbul Medeniyet University, Istanbul Medipol University Hospital, Istanbul University, Dr. Behcet Uz Children's Hospital, Kahramanmaras Megapark Hospital, Kahramanmaras Sutcu Imam University, Kanuni Sultan Suleyman Training and Research Hospital, Karadeniz Technical University, TC Erciyes University, Kecioren Education and Training Hospital, Kırıkkale University, Konya Baskent University, Konya Meram State Hospital, Selcuk University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Marmara University, Medical Park Gaziantep Hospital, Mersin Maternity Hospital, NCR International Hospital, Necmettin Erbakan University, Ozel Medova Hospital, Pamukkale University, Umraniye Education and Research Hospital, Inonu University, Sami Ulus Maternity and Children Hospital, Ondokuz Mayıs University, Suleymaniye Birth And Women's Health Education And Research Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Tepecik Training and Research Hospital, Tokat Gaziosmanpasa University, Trabzon Kanuni Education and Research Hospital, Trakya University, Yuksek Ihtisas University, Yuzuncu Yil University, Zekai Tahir Burak Women's Health Research and Education Hospital, Zeynep Kamil Maternity and Pediatric Research and Training Hospital, Muğla Sıtkı Koçman University, Koç University
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm babies screened for ROP.
Key inclusion criteria (1 listed)
- 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.
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 in Turkey
Time frame: 12 months
Incidence of ROP and severe ROP in relation to GA and BW in Turkey
11 secondary outcomes
The association of antenatal corticosteroid administration with ROP
Time frame: 12 months
The role of sepsis in infants in the development of ROP
Time frame: 12 months
The relationship between rate of postnatal weight gain and severity of ROP
Time frame: 12 months
The relationship between breastfeeding and ROP development
Time frame: 12 months
ROP in SGA premature infants
Time frame: 12 months
ROP in multiple births
Time frame: 12 months
The role of transfusions in ROP development
Time frame: 12 months
Duration of oxygen therapy among infants with and without ROP
Time frame: 12 months
Number of patients requiring laser photocoagulation treatment
Time frame: 12 months
Number of patients requiring vitreoretinal surgery
Time frame: 12 months
Number of patients requiring anti-vascular endothelial growth factor treatment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- 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.
- Derived from this study: 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.
- 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.
Ahmet Y Bas, MD principal investigator
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Nihal Demirel, MD principal investigator
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
İbrahim M Hirfanoglu, MD principal investigator
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 Etlik Zubeyde Hanım Women's Health Care, Training and Research 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: finished, as of the sponsor's last update on 11 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ROP in Turkey (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 NCT02814929, which also lists 2 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 11 Sep 2023.