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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
Sponsor:
Collaborators:
Acibadem Atakent University Hospital
Baskent University
Adana Numune Training and Research Hospital
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 State Hospital
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 Maternity and Children 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
Information provided by (Responsible Party):
Ahmet Yagmur BAS, 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.

Condition or disease
Retinopathy of Prematurity

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.


Study Type : Observational
Actual Enrollment : 6115 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Incidence of ROP in Turkey [ Time Frame: 12 months ]
    Incidence of ROP and severe ROP in relation to GA and BW in Turkey


Secondary Outcome Measures :
  1. The association of antenatal corticosteroid administration with ROP [ Time Frame: 12 months ]
  2. 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

  3. The relationship between rate of postnatal weight gain and severity of ROP [ Time Frame: 12 months ]
  4. The relationship between breastfeeding and ROP development [ Time Frame: 12 months ]
  5. ROP in SGA premature infants [ Time Frame: 12 months ]
    Comparison of ROP in SGA infants with those of appropriate size for GA

  6. ROP in multiple births [ Time Frame: 12 months ]
    Comparison of the frequency and severity of ROP among singleton and multiple-birth neonates

  7. The role of transfusions in ROP development [ Time Frame: 12 months ]
  8. Duration of oxygen therapy among infants with and without ROP [ Time Frame: 12 months ]
  9. Number of patients requiring laser photocoagulation treatment [ Time Frame: 12 months ]
  10. Number of patients requiring vitreoretinal surgery [ Time Frame: 12 months ]
  11. Number of patients requiring anti-vascular endothelial growth factor treatment [ Time Frame: 12 months ]

Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm babies screened for ROP.
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.

Information from the National Library of Medicine

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


Locations
Turkey
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Ankara, Keçi̇ören, Turkey, 06100
Sponsors and Collaborators
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Acibadem Atakent University Hospital
Baskent University
Adana Numune Training and Research Hospital
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 State Hospital
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 Maternity and Children 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
Investigators
Principal Investigator: Ahmet Y Bas, MD Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Principal Investigator: Nihal Demirel, MD Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Principal Investigator: İbrahim M Hirfanoglu, MD Gazi University
Principal Investigator: Dilek U Isik, MD Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Principal Investigator: Turan Tunc, MD Istanbul
Principal Investigator: Esin Koc, MD Gazi University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ahmet Yagmur BAS, Neonatologist, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02814929     History of Changes
Other Study ID Numbers: Turkey ROP Study
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ahmet Yagmur BAS, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital:
ROP
Risk factors
Incidence
Turkey

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases