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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retinopathy of Prematurity

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Demographic and Prenatal Characteristics<br>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<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ROP in Turkey | Incidence of ROP and severe ROP in relation to GA and BW in Turkey | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association of antenatal corticosteroid administration with ROP |  | 12 months | 
| The role of sepsis in infants in the development of ROP | 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 |  | 12 months | 
| The relationship between breastfeeding and ROP development |  | 12 months | 
| ROP in SGA premature infants | Comparison of ROP in SGA infants with those of appropriate size for GA | 12 months | 
| ROP in multiple births | Comparison of the frequency and severity of ROP among singleton and multiple-birth neonates | 12 months | 
| The role of transfusions in ROP development |  | 12 months | 
| Duration of oxygen therapy among infants with and without ROP |  | 12 months | 
| Number of patients requiring laser photocoagulation treatment |  | 12 months | 
| Number of patients requiring vitreoretinal surgery |  | 12 months | 
| Number of patients requiring anti-vascular endothelial growth factor treatment |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROP, Risk factors, Incidence, Turkey