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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28+
SponsorBaskent University Ankara Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Infants with BW \>1500 g or ≥33 weeks' gestation who were screened for ROP.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Incidence of ROP

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

Time frame
12 months

Secondary outcomes

1

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

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

Time frame
12 months
2

The role of sepsis in infants in the development of ROP

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

Time frame
12 months
3

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

Duration of invasive mechanical ventilation during NICU admission

Time frame
12 months
4

The role of chorioamnionitis in infants in the development of ROP

The number of infants whose mothers with clinical/histological chorioamnionitis

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baskent University Ankara Hospital

Lead sponsor

Hacettepe University

Collaborator

Gazi University

Collaborator

Gaziosmanpasa Research and Education Hospital

Collaborator

Celal Bayar University

Collaborator

Selcuk University

Collaborator

Recep Tayyip Erdogan University

Collaborator

Karadeniz Technical University

Collaborator

Istinye University

Collaborator

Biruni University

Collaborator

Ordu University

Collaborator

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Collaborator

Pamukkale University

Collaborator

Kanuni Sultan Suleyman Training and Research Hospital

Collaborator

Konya City Hospital

Collaborator

Kecioren Education and Training Hospital

Collaborator

Ataturk University

Collaborator

Meda Hospital

Collaborator

Eskisehir Osmangazi University

Collaborator

Necmettin Erbakan University

Collaborator

Kırıkkale University

Collaborator

Sisli Hamidiye Etfal Training and Research Hospital

Collaborator

Acibadem Atakent University Hospital

Collaborator

Balikesir Ataturk City Hospital

Collaborator

Kocaeli University

Collaborator

Acibadem Maslak Hospital

Collaborator

Erzurum City Hospital

Collaborator

Afyon Karahisar Hospital

Collaborator

Ankara Koru Hospital

Collaborator

Gulhane School of Medicine

Collaborator

Bursa Yuksek Ihtisas Training and Research Hospital

Collaborator

Namik Kemal University

Collaborator

Bursa City Hospital

Collaborator

Kayseri City Hospital

Collaborator

Ankara Etlik City Hospital

Collaborator

Zonguldak Bulent Ecevit University

Collaborator

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Collaborator

Inonu University

Collaborator

Dr. Behcet Uz Children's Hospital

Collaborator

Ankara Training and Research Hospital

Collaborator

Tepecik Training and Research Hospital

Collaborator

Aydin Adnan Menderes University

Collaborator

Dicle University

Collaborator

Akdeniz University

Collaborator

Umraniye Education and Research Hospital

Collaborator

Ankara City Hospital Bilkent

Collaborator

Afyonkarahisar University of Health Sciences Health Application and Research Center

Collaborator

Harran University

Collaborator

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Collaborator

Istanbul University - Cerrahpasa

Collaborator

Uludag University

Collaborator

Sanliurfa Education and Research Hospital

Collaborator

Dokuz Eylul University

Collaborator

Bursa Doruk Yıldırım Hospital

Collaborator

Malatya Turgut Ozal University

Collaborator

Abant Izzet Baysal University

Collaborator

Alanya Training and Research Hospital

Collaborator

İstanbul Training and Research Hospital

Collaborator

Baskent University

Collaborator

Kahramanmaras Sutcu Imam University

Collaborator

Batman Training and Research Hospital

Collaborator

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

Collaborator

Acıbadem Atunizade Hospital

Collaborator

Adiyaman Training and Research Hospital

Collaborator

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Collaborator

Ondokuz Mayıs University

Collaborator

Trakya University

Collaborator

Trabzon Kanuni Education and Research Hospital

Collaborator

Seyhan Hospital

Collaborator

Esenyurt University Hospital

Collaborator

Başakşehir Çam & Sakura City Hospital

Collaborator

Sakarya University

Collaborator

Mardin Training and Research Hospital

Collaborator

Karabuk University

Collaborator

Giresun Training and Research Hospital

Collaborator

Koc University Hospital

Collaborator

Tekirdağ City Hospital

Collaborator

Istanbul Medipol University Hospital

Collaborator

Adana City Training and Research Hospital

Collaborator

Istanbul University

Collaborator

Marmara University Pendik Training and Research Hospital

Collaborator

Medikal Park Ankara Hospital

Collaborator

Muğla Sıtkı Koçman University

Collaborator

Yuzuncu Yil University

Collaborator

Sanko University

Collaborator

Antalya Training and Research Hospital

Collaborator

Firat University

Collaborator

Ankara Guven Hospital

Collaborator

Private Batman Hospital

Collaborator

İstanbul Bağcılar Training and Research Hospital

Collaborator

Istanbul Aydın University

Collaborator

Mersin City Hospital

Collaborator