Condition category
Eye Diseases
Date applied
07/06/2020
Date assigned
14/08/2020
Last edited
06/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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
mbrakdogan@yahoo.com

Trial website

Contact information

Type

Public

Primary contact

Prof Muberra Akdogan

ORCID ID

http://orcid.org/0000-0003-4846-312X

Contact details

Zafer Saglik Kulliyesi
Dortyol Mah. 2078 Sok. No3
Afyon
03200
Turkey
+90 5052408229
mbrakdogan@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Correlation between Systemic Immun-Inflammation index and routine hemogram related inflammatory markers in prognosis of Retinopathy Of Prematurity (SII ROP)

Acronym

SII ROP

Study hypothesis

To evaluate the prognostic potential of the systemic immune-inflammation index in patients with retinopathy of prematurity (ROP).

Ethics approval

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.

Study design

Retrospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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

01/07/2016

Overall trial end date

01/06/2018

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

303 infants

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

01/05/2016

Recruitment end date

01/02/2018

Locations

Countries of recruitment

Turkey

Trial participating centre

Bursa Yuksek Ihtisas Education and Research Hospital
Mimar Sinan, No: Emniyet Cd. No:35
Bursa
16310
Turkey

Trial participating centre

Afyonkarahisar Health Sciences University Hospital
Zafer Saglik Kulliyesi Dortyol Mah. 2078 Sok. No3
Afyon
03200
Turkey

Sponsor information

Organisation

Bursa Yuksek Ihtisas Education And Research Hospital

Sponsor details

Mimar Sinan Mah. Emniyet Cad.
Polis Okulu Karşısı Yıldırım
Bursa
16110
Turkey
+90 5052408229
bursaeah1@saglik.gov.tr

Sponsor type

Hospital/treatment centre

Website

https://bursayuksekihtisaseah.saglik.gov.tr/

Funders

Funder type

Government

Funder name

National Institutes of Health

Alternative name(s)

NIH

Funding Body Type

unknown

Funding Body Subtype

Location

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

01/07/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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