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

Retinopathy of Prematurity Clinical Trial

— TR-ROP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814929
• Other study ID #: Turkey ROP Study
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: October 17, 2017

Study information

• Verified date: September 2023
• Source: Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6115
• Est. completion date: October 17, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days and older

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Locations

Country	Name	City	State
Turkey	Etlik Zubeyde Hanim Womens' Health and Teaching Hospital	Ankara	Keçi?ören

Sponsors (69)

Lead Sponsor

Collaborator

Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

Acibadem Atakent University Hospital, Adana Numune Training and Research Hospital, Ankara Guven Hospital, Ankara University, Atasehir Kadikoy Sifa Hospital, Ataturk University, Aydin Adnan Menderes University, Bagcilar Training and Research Hospital, Baskent University, Baskent University Ankara Hospital, Bezmialem Vakif University, Bulent Ecevit University, Canakkale 18 Mart University, Cengiz Gokcek Women's and Children's Hospital, Cukurova University, Denizli Devlet Hastanesi, Denizli Ozel Saglik Hospital, Dicle University, Dokuz Eylul University, Dortcelik Children Hospital, Doruk Bursa Hospital, Dr. Behcet Uz Children's Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Ege University, Erzurum Nenehatun Maternity Hospital, Eskisehir Osmangazi University, Faruk Sukan Maternity and Children Hospital, Firat University, Hacettepe University, Inonu University, Istanbul Medeniyet University, Istanbul Medipol University Hospital, Istanbul University, Kahramanmaras Megapark Hospital, Kahramanmaras Sutcu Imam University, Kanuni Sultan Suleyman Training and Research Hospital, Karadeniz Technical University, Kecioren Education and Training Hospital, Kirikkale University, Koç University, Konya Baskent University, Konya Meram State Hospital, Marmara University, Medical Park Gaziantep Hospital, Mersin Maternity Hospital, Mugla Sitki Koçman University, Mustafa Kemal University, NCR International Hospital, Necmettin Erbakan University, Ondokuz Mayis University, Ozel Medova Hospital, Pamukkale University, Sami Ulus Maternity and Children Hospital, Selcuk University, Sisli Hamidiye Etfal Training and Research Hospital, Suleymaniye Birth And Women's Health Education And Research Hospital, TC Erciyes University, Tepecik Training and Research Hospital, Tokat Gaziosmanpasa University, Trabzon Kanuni Education and Research Hospital, Trakya University, Uludag University, Umraniye Education and Research Hospital, University of Gaziantep, 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

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of ROP in preterm babies of refugees in Turkey	Incidence of any ROP and severe ROP in relation to GA and BW in preterm babies of refugees	12 months
Primary	Incidence of ROP in Turkey	Incidence of ROP and severe ROP in relation to GA and BW in Turkey	12 months
Secondary	The association of antenatal corticosteroid administration with ROP		12 months
Secondary	The role of sepsis in infants in the development of ROP	Culture proven and clinical early and late sepsis will be evaluated	12 months
Secondary	The relationship between rate of postnatal weight gain and severity of ROP		12 months
Secondary	The relationship between breastfeeding and ROP development		12 months
Secondary	ROP in SGA premature infants	Comparison of ROP in SGA infants with those of appropriate size for GA	12 months
Secondary	ROP in multiple births	Comparison of the frequency and severity of ROP among singleton and multiple-birth neonates	12 months
Secondary	The role of transfusions in ROP development		12 months
Secondary	Duration of oxygen therapy among infants with and without ROP		12 months
Secondary	Number of patients requiring laser photocoagulation treatment		12 months
Secondary	Number of patients requiring vitreoretinal surgery		12 months
Secondary	Number of patients requiring anti-vascular endothelial growth factor treatment		12 months