The role of inflammation in the outcomes of retinopathy of prematurity
| ISRCTN | ISRCTN16473879 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16473879 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Bursa Yuksek Ihtisas Education And Research Hospital |
| Funder | National Institutes of Health |
- 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
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
Public
Zafer Saglik Kulliyesi
Dortyol Mah. 2078 Sok. No3
Afyon
03200
Türkiye
 ORCID ID |
0000-0003-4846-312X |
|---|---|
| Phone | +90 5052408229 |
| mbrakdogan@yahoo.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective cohort study |
| Secondary study design | Cohort study |
| Study type | 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(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 303 |
| 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
Emniyet Cd. No:35
Bursa
16310
Türkiye
Dortyol Mah. 2078 Sok. No3
Afyon
03200
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/06/2020: Trial’s existence confirmed by Bursa Yuksek Ihtisas Education And Research Hospital Clinical Research Ethics Committee .
