Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey (TR-ROP)
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|ClinicalTrials.gov Identifier: NCT02814929|
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : October 19, 2017
|Condition or disease|
|Retinopathy of Prematurity|
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 Type :||Observational|
|Actual Enrollment :||6115 participants|
|Official Title:||Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey: A Prospective Multicenter Study Including 69 NICUs|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||August 1, 2017|
|Actual Study Completion Date :||October 17, 2017|
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.
- Incidence of ROP in Turkey [ Time Frame: 12 months ]Incidence of ROP and severe ROP in relation to GA and BW in Turkey
- 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 ]Culture proven and clinical early and late sepsis will be evaluated
- 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 ]Comparison of ROP in SGA infants with those of appropriate size for GA
- ROP in multiple births [ Time Frame: 12 months ]Comparison of the frequency and severity of ROP among singleton and multiple-birth neonates
- 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 ]
- Incidence of ROP in preterm babies of refugees in Turkey [ Time Frame: 12 months ]Incidence of any ROP and severe ROP in relation to GA and BW in preterm babies of refugees
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814929
|Etlik Zubeyde Hanim Womens' Health and Teaching Hospital|
|Ankara, Keçi̇ören, Turkey, 06100|
|Principal Investigator:||Ahmet Y Bas, MD||Etlik Zubeyde Hanim Womens' Health and Teaching Hospital|
|Principal Investigator:||Nihal Demirel, MD||Etlik Zubeyde Hanim Womens' Health and Teaching Hospital|
|Principal Investigator:||İbrahim M Hirfanoglu, MD||Gazi University|
|Principal Investigator:||Dilek U Isik, MD||Etlik Zubeyde Hanim Womens' Health and Teaching Hospital|
|Principal Investigator:||Turan Tunc, MD||Istanbul|
|Principal Investigator:||Esin Koc, MD||Gazi University|