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

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

Sponsors

Lead Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Collaborator: 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 Training and Research 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
İnonu 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 Yıl 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

Source Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Brief 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.

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.

Overall Status Completed
Start Date 2016-04-01
Completion Date 2017-10-17
Primary Completion Date 2017-08-01
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of ROP in Turkey 12 months
Secondary Outcome
Measure Time Frame
The association of antenatal corticosteroid administration with ROP 12 months
The role of sepsis in infants in the development of ROP 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 12 months
ROP in multiple births 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
Enrollment 6115
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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.

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Location Countries

Turkey

Verification Date

2017-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Investigator Full Name: Ahmet Yagmur BAS

Investigator Title: Neonatologist

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Demographic and Prenatal Characteristics

Description: Gender, multiple pregnancy antenatal steroid therapy, invitro fertilisation, preeclampsia/eclampsia, infants of diabetic mother, chorioamnionitis will be compared among infants with and without ROP

Label: Neonatal Characteristics of infants

Description: 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.

Label: Incidence of any ROP and severe ROP

Description: 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.

Acronym TR-ROP
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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