Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey.

Retinopathy of Prematurity Clinical Trial

— TR-BigROP  

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. (TR-BigROP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265363
• Other study ID #: Turkey BigROP Study
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: Baskent University Ankara Hospital
• Contact: Sezin Unal
• Phone: 0090532
• Email: sezinunal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara

Sponsors (93)

Lead Sponsor

Collaborator

Baskent University Ankara Hospital

Abant Izzet Baysal University, Acibadem Atakent University Hospital, Acibadem Atunizade Hospital, Acibadem Maslak Hospital, Adana City Training and Research Hospital, Adiyaman Training and Research Hospital, Afyon Karahisar Hospital, Afyonkarahisar University of Health Sciences Health Application and Research Center, Akdeniz University, Alanya Training and Research Hospital, Ankara Bilkent City Hospital, Ankara Etlik City Hospital, Ankara Güven Hospital, Ankara Koru Hospital, Ankara Training and Research Hospital, Antalya Training and Research Hospital, Ataturk University, Aydin Adnan Menderes University, Balikesir Ataturk City Hospital, Basaksehir Cam & Sakura Sehir Hospital, Baskent Univeristy Adana Hospital, Batman Training and Research Hospital, Biruni University, Bursa City Hospital, Bursa Doruk Yildirim Hospital, Bursa Yüksek Ihtisas Education and Research Hospital, Celal Bayar University, Dicle University, Dokuz Eylul University, Dr. Behcet Uz Children's Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Erzurum City Hospital, Esenyurt University Hospital, Eskisehir Osmangazi University, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital, Firat University, Gazi University, Gazi Yasargil Training and Research Hospital, Gaziosmanpasa Research and Education Hospital, Giresun Training and Research Hospital, Hacettepe University, Harran University, Inonu University, Istanbul Aydin University, Istanbul Bagcilar Training and Research Hospital, Istanbul Training and Research Hospital, Istanbul University, Istanbul University - Cerrahpasa (IUC), Istinye University, Kahramanmaras Sutcu Imam University, Kanuni Sultan Suleyman Training and Research Hospital, Karabuk University, Karadeniz Technical University, Kayseri City Hospital, Kecioren Education and Training Hospital, Kirikkale University, Koc University Hospital, Kocaeli University, Konya City Hospital, Malatya Turgut Ozal University, Mardin Training and Research Hospital, Marmara University Pendik Training and Research Hospital, Meda Hospital, Medikal Park Ankara Hospital, Medipol University Bahcelievler Hospital, Medipol University Mega Hospital, Mersin City Hospital, Mugla Sitki Koçman University, Namik Kemal University, Necmettin Erbakan University, Ondokuz Mayis University, Pamukkale University, Private Batman Hospital, Recep Tayyip Erdogan University, Sakarya University, Sanko University, Sanliurfa Mehmet Akif Inan Education and Research Hospital, sanliurfa training and research Hospital, Selcuk University, Seyhan Hospital, Sisli Hamidiye Etfal Training and Research Hospital, T.C. ORDU ÜNIVERSITESI, Tekirdag City Hospital, Tepecik Training and Research Hospital, Trabzon Kanuni Education and Research Hospital, Trakya University, Uludag University, Umraniye Education and Research Hospital, University of Health Sciences Gulhane Hospital, Yuzuncu Yil University, Zeynep Kamil Maternity and Pediatric Research and Training Hospital, Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 Oph — View Citation

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. — View Citation

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-Cas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ROP	Incidence of ROP and severe ROP in infants > 1500 gr and gestational age = 33 weeks in Turkey	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	The role of mechanical ventilation in infants in the development of ROP	Duration of invasive mechanical ventilation during NICU admission	12 months
Secondary	The role of chorioamnionitis in infants in the development of ROP	The number of infants whose mothers with clinical/histological chorioamnionitis	12 months
Secondary	Laser photocoagulation treatment	Number of patients requiring laser photocoagulation treatment	12 months
Secondary	Anti-VEGF treatment	Number of patients requiring anti-VEGF treatment	12 months
Secondary	Vitreoretinal surgery	Number of patients requiring vitreoretinal surgery	12 months