The role of inflammation in the outcomes of retinopathy of prematurity

ISRCTN	ISRCTN16473879
DOI	https://doi.org/10.1186/ISRCTN16473879

Submission date: 07/06/2020
Registration date: 14/08/2020
Last edited: 06/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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
mbrakdogan@yahoo.com

Contact information

Prof Muberra Akdogan
Public

Zafer Saglik Kulliyesi
Dortyol Mah. 2078 Sok. No3
Afyon
03200
Türkiye

ORCID ID	0000-0003-4846-312X
Phone	+90 5052408229
Email	mbrakdogan@yahoo.com

Study information

Study design	Retrospective cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Correlation between Systemic Immun-Inflammation index and routine hemogram related inflammatory markers in prognosis of Retinopathy Of Prematurity (SII ROP)
Study acronym	SII ROP
Study objectives	To evaluate the prognostic potential of the systemic immune-inflammation index in patients with retinopathy of prematurity (ROP).
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	Retinopathy of prematurity
Intervention	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.
Intervention type	Not Specified
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 study start date	01/07/2016
Completion date	01/06/2018

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	303 infants
Key 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
Key exclusion criteria	1. Sepsis proven in blood culture 2. Necrotizing enterocolitis 3. Hematological disease 4. Receiving blood product transfusion or steroid treatment
Date of first enrolment	01/05/2016
Date of final enrolment	01/02/2018

Locations

Countries of recruitment

Türkiye

Study participating centres

Bursa Yuksek Ihtisas Education and Research Hospital

Mimar Sinan, No:
Emniyet Cd. No:35
Bursa
16310
Türkiye

Afyonkarahisar Health Sciences University Hospital

Zafer Saglik Kulliyesi
Dortyol Mah. 2078 Sok. No3
Afyon
03200
Türkiye

Sponsor information

Bursa Yuksek Ihtisas Education And Research Hospital
Hospital/treatment centre

Mimar Sinan Mah. Emniyet Cad.
Polis Okulu Karşısı Yıldırım
Bursa
16110
Türkiye

Phone	+90 5052408229
Email	bursaeah1@saglik.gov.tr
Website	https://bursayuksekihtisaseah.saglik.gov.tr/
"ROR"	https://ror.org/05nhkt138

Funders

Funder type

Government

National Institutes of Health
Government organisation / National government

Alternative name(s): Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location: United States of America

Results and Publications

Intention to publish date	01/07/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Editorial Notes

17/06/2020: Trial’s existence confirmed by Bursa Yuksek Ihtisas Education And Research Hospital Clinical Research Ethics Committee .