Clinical trial NCT02814929: Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey
Official title: Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey: A Prospective Multicenter Study Including 69 NICUs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Keywords: ROP
Risk factors
Incidence
Turkey
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Acibadem Atakent University Hospital
name: Baskent University
name: Adana Numune Training and Research Hospital
name: Aydin Adnan Menderes University
name: Ankara University
name: Baskent University Ankara Hospital
name: Ankara Guven Hospital
name: Ataşehir Kadıkoy Sifa Hospital
name: Ataturk University
name: Bagcilar Training and Research Hospital
name: Bezmialem Vakif University
name: Dortcelik Children Hospital
name: Uludag University
name: Bulent Ecevit University
name: Canakkale 18 Mart University
name: Cukurova University
name: Denizli Devlet Hastanesi
name: Denizli Ozel Saglik Hospital
name: Dicle University
name: Dokuz Eylul University
name: Doruk Bursa Hospital
name: Faruk Sukan Maternity and Children Hospital
name: Ege University
name: Erzurum Nenehatun Maternity Hospital
name: Eskisehir Osmangazi University
name: Firat University
name: Cengiz Gokcek Women's and Children's Hospital
name: University of Gaziantep
name: Mustafa Kemal University
name: Hacettepe University
name: Istanbul Medeniyet University
name: Istanbul Medipol University Hospital
name: Istanbul University
name: Dr. Behcet Uz Children's Hospital
name: Kahramanmaras Megapark Hospital
name: Kahramanmaras Sutcu Imam University
name: Kanuni Sultan Suleyman Training and Research Hospital
name: Karadeniz Technical University
name: TC Erciyes University
name: Kecioren Education and Training Hospital
name: Kırıkkale University
name: Konya Baskent University
name: Konya Meram State Hospital
name: Selcuk University
name: Dr. Lutfi Kirdar Kartal Training and Research Hospital
name: Marmara University
name: Medical Park Gaziantep Hospital
name: Mersin Maternity Hospital
name: NCR International Hospital
name: Necmettin Erbakan University
name: Ozel Medova Hospital
name: Pamukkale University
name: Umraniye Education and Research Hospital
name: Inonu University
name: Sami Ulus Maternity and Children Hospital
name: Ondokuz Mayıs University
name: Suleymaniye Birth And Women's Health Education And Research Hospital
name: Sisli Hamidiye Etfal Training and Research Hospital
name: Tepecik Training and Research Hospital
name: Tokat Gaziosmanpasa University
name: Trabzon Kanuni Education and Research Hospital
name: Trakya University
name: Yuksek Ihtisas University
name: Yuzuncu Yıl University
name: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
name: Muğla Sıtkı Koçman University
name: Koç University
First posted: 2016-06-28
Enrollment: 6115
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm babies screened for ROP.

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of ROP in Turkey
timeFrame: 12 months
Secondary outcomes:
measure: The association of antenatal corticosteroid administration with ROP
timeFrame: 12 months
measure: The role of sepsis in infants in the development of ROP
timeFrame: 12 months
measure: The relationship between rate of postnatal weight gain and severity of ROP
timeFrame: 12 months
measure: The relationship between breastfeeding and ROP development
timeFrame: 12 months
measure: ROP in SGA premature infants
timeFrame: 12 months
measure: ROP in multiple births
timeFrame: 12 months
measure: The role of transfusions in ROP development
timeFrame: 12 months
measure: Duration of oxygen therapy among infants with and without ROP
timeFrame: 12 months
measure: Number of patients requiring laser photocoagulation treatment
timeFrame: 12 months
measure: Number of patients requiring vitreoretinal surgery
timeFrame: 12 months
measure: Number of patients requiring anti-vascular endothelial growth factor treatment
timeFrame: 12 months
Other outcomes:
measure: Incidence of ROP in preterm babies of refugees in Turkey
timeFrame: 12 months
Locations:
city: Ankara
country: Turkey
facility: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
state: Keçi̇ören
Study officials:
affiliation: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
name: Ahmet Y Bas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
name: Nihal Demirel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: İbrahim M Hirfanoglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
name: Dilek U Isik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul
name: Turan Tunc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Esin Koc, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 Ophthalmol. 2018 Dec;102(12):1711-1716. doi: 10.1136/bjophthalmol-2017-311789. Epub 2018 Mar 8.