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HOPE Scientific studies

EPITOP

Study:  Risk factors for retinopathy of prematurity – EPITOP a register study.

Collaborating parties: University of Gothenburg and Lund University.

Read more about the study: https://kaw.wallenberg.org/forskning/hon-vill-ge-tidigt-fodda-barn-ett-battre-liv

Background and purpose

Extreme preterm birth means care on a neonatal ward. While hospitalised, the condition of the infant is monitored with different methods, including  blood sampling. When analyses of these samples is complete, there is a small amount of blood left in the sampling test tube (0.1 ml), which is currently discarded. Investigators in the EPITOP project want to examine whether the residual samples can be used to study different substances in the blood (so-called biomarkers) and see if these can be used to identify at an early stage, which infants are at high risk of various diseases linked to premature birth, including the eye disease, retinopathy of prematurity (ROP), as well as diseases that affect other organs in the body such as the  lungs, intestine and brain.

Use of HOPE

HOPE Platform provides the university hospital departments with a technical assistance advantage, enabling information to be displayed in different ways in different technical environments. An added advantage is that HOPE Platform also gives investigators complete oversight of data gathered and full control over the rate at which data is collected. HOPE Platform ensures that data are always used in accordance with statutory requirements, as well as in a secure, responsible and considerate manner. HOPE App is used by parents and HOPE Practitioner is used by clinical nurses and researchers. HOPE Platform is used to gather values and conditions needed for the study. Research nurses use HOPE Practitioner to register additional values and conditions. Researchers use HOPE Platform to manage consent, communicate with parents and collect and process information for the study.

Samples stored in Biobank

The samples stored in connection with this study will be stored at Biobank Väst (registration number 890 at the Swedish Health and Social Care Inspectorate (IVO)) in accordance with the Swedish Biobanks in Medical Care Act (2002:297). The Act regulates the way in which samples may be stored and used, as well as regulating  the quality and security of biobanks. Biobanken Väst is the common biobank for Region Västra Götaland. Samples in the study will be stored pending analysis for a maximum of 5 years if consent is given for future studies or will be destroyed if consent is not given fro future research. The samples will be stored coded, which means that they cannot be directly linked to your child as a person. Every sample has a unique code to avoid confusion. The samples and associated identification list (code key) will be stored at Biobank Väst separated from each other and protected from unauthorised access. Pseudonymised samples may be released outside  the principal research body, i.e. samples may be analysed by partners, industry and pharmaceutical companies within the EU/EEA and/or the USA. The samples will be returned or destroyed after analysis.

“HOPE Platform offers us a holistic solution. It gives us a simple way to obtain parents' approval for the study and create a feasibility database for future research, while giving parents easy and up-to-date access to information.”

Ann Hellström, Professor of Paediatric Ophthalmology, Drottning Silvias Barn- och Ungdomssjukhus, Sahlgrenska University Hospital, Region Västra Götaland