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NCT Number: NCT06265363

Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey.

The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of >1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity 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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

28 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baskent University

Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ahmet Y Bas, Prof

PRINCIPAL_INVESTIGATOR

Esin Koc, Prof

PRINCIPAL_INVESTIGATOR

Sezin Unal

CONTACT

[email protected]

0090532

İbrahim M Hirfanoğlu, Prof

PRINCIPAL_INVESTIGATOR

About this study

This study, promoted by the "Turkish Neonatology Society", involved preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in level III/IV Turkish NICUs.

An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network. Neonatologists working in 94 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 fertilization, 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), time to full enteral feeding, percentage of own mothers milk.

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 94 NICUs will be pooled together and analyzed.

The "International Classification of ROP" guidelines (ICROP-3) are used to record the stage of disease, location by zone, signs of plus disease and signs of regression/reactivation/persistent avascular retina.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants with BW >1500 g or ≥33 weeks' gestation who were determined to be at risk for ROP by the attending clinician and were screened for ROP.

Exclusion criteria

  • Neonates who died before the first ROP examination are excluded from the study.

Treatment and study plan

Primary outcomes

  1. Incidence of ROP

    Time frame: 12 months

    Incidence of ROP and severe ROP in infants > 1500 gr and gestational age ≥ 33 weeks in Turkey.

Secondary outcomes

  1. The role of being SGA in infants in the development of ROP

    Time frame: 12 months

    Number of infants with less than 10th percentile of birth weight according to Fenton graphs

  2. The role of sepsis in infants in the development of ROP

    Time frame: 12 months

    Number of infants diagnosed with early sepsis (< 3 days postnatal) or late sepsis (>3 days postnatal) during the NICU admission

  3. The role of mechanical ventilation in infants in the development of ROP

    Time frame: 12 months

    Duration of invasive mechanical ventilation during NICU admission

  4. The role of chorioamnionitis in infants in the development of ROP

    Time frame: 12 months

    The number of infants whose mothers with clinical/histological chorioamnionitis

  5. Laser photocoagulation treatment

    Time frame: 12 months

    Number of patients requiring laser photocoagulation treatment

  6. Anti-VEGF treatment

    Time frame: 12 months

    Number of patients requiring anti-VEGF treatment

  7. Vitreoretinal surgery

    Time frame: 12 months

    Number of patients requiring vitreoretinal surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Sezin Unal

CONTACT

[email protected]

0090532

Sponsors and collaborators

Lead sponsor

Baskent University Ankara Hospital

Other

Collaborators

  • Abant Izzet Baysal University
  • Acibadem Atakent University Hospital
  • Acibadem Maslak Hospital
  • Acıbadem Atunizade Hospital
  • Adana City Training and Research Hospital
  • Adiyaman Training and Research Hospital
  • Afyon Karahisar Hospital
  • Afyonkarahisar University of Health Sciences Health Application and Research Center
  • Akdeniz University
  • Alanya Training and Research Hospital
  • Ankara City Hospital Bilkent
  • Ankara Etlik City Hospital
  • Ankara Guven Hospital
  • Ankara Koru Hospital
  • Ankara Training and Research Hospital
  • Antalya Training and Research Hospital
  • Ataturk University
  • Aydin Adnan Menderes University
  • Balikesir Ataturk City Hospital
  • Baskent University
  • Batman Training and Research Hospital
  • Başakşehir Çam & Sakura City Hospital
  • Biruni University
  • Bursa City Hospital
  • Bursa Doruk Yıldırım Hospital
  • Bursa Yuksek Ihtisas Training and Research Hospital
  • Dicle University
  • Dokuz Eylul University
  • Dr. Behcet Uz Children's Hospital
  • Dr. Lutfi Kirdar Kartal Training and Research Hospital
  • Erzurum City Hospital
  • Esenyurt University Hospital
  • Eskisehir Osmangazi University
  • Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
  • Firat University
  • Gazi University
  • Gaziosmanpasa Research and Education Hospital
  • Giresun Training and Research Hospital
  • Gulhane School of Medicine
  • Hacettepe University
  • Harran University
  • Inonu University
  • Istanbul Aydın University
  • Istanbul Medipol University Hospital
  • Istanbul University
  • Istanbul University - Cerrahpasa
  • Istinye University
  • Kahramanmaras Sutcu Imam University
  • Kanuni Sultan Suleyman Training and Research Hospital
  • Karabuk University
  • Karadeniz Technical University
  • Kayseri City Hospital
  • Kecioren Education and Training Hospital
  • Koc University Hospital
  • Kocaeli University
  • Konya City Hospital
  • Kırıkkale University
  • Malatya Turgut Ozal University
  • Manisa Celal Bayar University
  • Mardin Training and Research Hospital
  • Marmara University Pendik Training and Research Hospital
  • Meda Hospital
  • Medikal Park Ankara Hospital
  • Mersin City Hospital
  • Muğla Sıtkı Koçman University
  • Namik Kemal University
  • Necmettin Erbakan University
  • Ondokuz Mayıs University
  • Ordu University
  • Pamukkale University
  • Private Batman Hospital
  • Recep Tayyip Erdogan University
  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  • Sakarya University
  • Sanko University
  • Sanliurfa Education and Research Hospital
  • Sanliurfa Mehmet Akif Inan Education and Research Hospital
  • Selcuk University
  • Seyhan Hospital
  • Sisli Hamidiye Etfal Training and Research Hospital
  • Tekirdağ City Hospital
  • Tepecik Training and Research Hospital
  • Trabzon Kanuni Education and Research Hospital
  • Trakya University
  • Uludag University
  • Umraniye Education and Research Hospital
  • Yuzuncu Yil University
  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital
  • Zonguldak Bulent Ecevit University
  • İstanbul Bağcılar Training and Research Hospital
  • İstanbul Training and Research Hospital

Registry information

Official study title

Evaluation of the Frequency of Retinopathy of Prematurity, Influencing Risk Factors, and Treatment Outcomes in Premature Infants With a Birth Weight >1500 Grams or Gestational Age ≥33 Weeks in Turkey.

Acronym: TR-ROP-2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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