Plain English Summary
Background and study aims
Retinopathy of prematurity (ROP) is a disease caused by abnormal development of the blood vessels in premature (born early) infants. This can mean loss of function of the retina, the inner layer of the eye that receives light and turns it into visual messages that are sent to the brain. ROP can in some cases lead to blindness. Steroids given to mothers who are likely to give birth prematurely can reduce the chance of complications of prematurity such as ROP.
Recent studies report that inflammation is associated with retinopathy of prematurity (ROP). In addition, it has been revealed that general inflammation can lead to problems with retinal blood vessel development and symptoms of ROP in newborn animals. This trial aims to see if measuring levels of inflammation (using levels of white blood cells as a marker of inflammation) can predict the likelihood and severity of ROP.
Who can participate?
Data will be collected from premature infants (born before 35 weeks gestation)
What does the study involve?
This is an observational trial. All information will be obtained from the patient’s hospital file and there will be no changes to patient care as part of the study. The information collected will be: whether the participants had developed ROP; and the complete blood count (CBC) from blood samples taken within 72 hours of birth and one month after birth.
What are the possible benefits and risks of participating?
This is an observational trial so there are no anticipated risks with participation.
Where is the study run from?
Bursa Yuksek Ihtisas Education And Research Hospital (Turkey)
When is the study starting and how long is it expected to run for?
From February 2016 to February 2018
Who is funding the study?
National Institutes of Health (USA)
Who is the main contact?
Prof Muberra Akdogan
Correlation between Systemic Immun-Inflammation index and routine hemogram related inflammatory markers in prognosis of Retinopathy Of Prematurity (SII ROP)
To evaluate the prognostic potential of the systemic immune-inflammation index in patients with retinopathy of prematurity (ROP).
Approved 09/06/2018, Bursa Yuksek Ihtisas Education And Research Hospital Clinical Research Ethics Committee (Mimar Sinan Mah. Emniyet Cad. Yıldırım, Bursa, 16310 Turkey; +90 (0)224 295 52 83), ref: 2011-KAEK-25 2018/09-06.
Retrospective cohort study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Retinopathy of prematurity
There is no intervention as this is an observational trial. All data will be obtained from the patient’s hospital file for premature participants without ROP, and with early-stage ROP, aggressive posterior ROP (APROP), and advanced stage ROP. The data collected will be whether the participants had developed ROP and Complete blood count (CBC) at birth and one month after birth. The CBC will be used to calculate the Serum neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte (PLR) and Systemic Immune-inflammation Index (SII) for particpiants at birth and one month after. LMR was calculated by dividing the absolute lymphocyte count by the absolute monocyte count. NLR and PLR were determined by dividing the absolute neutrophil count or the absolute platelet count by the absolute lymphocyte count, respectively. The SII was calculated by the dividing the product of the absolute neutrophil count and the absolute platelet count by the absolute lymphocyte count.
Primary outcome measure
Significance of Systemic Immune-inflammation Index (SII) values in the development period of ROP measured from Complete blood count (CBC) at birth and one month after birth
Secondary outcome measures
Prediction of the development of ROP using white blood cell (WBC) ratios such as neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte (PLR) and Systemic Immune-inflammation Index (SII) values measured from Complete blood count (CBC) at birth and one month after birth
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Complete blood counts (CBC) measured both <72 h after birth and one month after birth
2. Delivered at gestational age of ≤35 weeks
Target number of participants
Participant exclusion criteria
1. Sepsis proven in blood culture
2. Necrotizing enterocolitis
3. Hematological disease
4. Receiving blood product transfusion or steroid treatment
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Bursa Yuksek Ihtisas Education and Research Hospital
Mimar Sinan, No: Emniyet Cd. No:35
Trial participating centre
Afyonkarahisar Health Sciences University Hospital
Zafer Saglik Kulliyesi Dortyol Mah. 2078 Sok. No3
National Institutes of Health
The National Institutes of Health, NIH
Funding Body Type
Funding Body Subtype
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Basic results (scientific)