Frequently Asked Questions
What does taking part in the study involve?
If your baby is currently in hospital and has a stoma formed, the doctors looking after them may have mentioned the ToSCiN study to you. If your baby is enrolled in this study, it will not change their treatment and will not involve any additional tests or procedures. We will just observe how your baby is doing while they are in hospital.
If you are a parent of a baby enrolled in the study, or of a child who previously had a stoma, with your permission, we would also like to ask you some questions on the phone or via an online platform. This would last about 45 minutes and take place once.
Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. You and your child will not be identified in any report or publication about the study. Read more information about how we process and protect your data.
Who can take part in this study?
Babies can be enrolled in this study if they have a stoma formed as part of emergency surgery before they are 44 weeks old (post-conceptual age).
Babies who have had a stoma formed as part of a planned treatment pathway (for instance, for an anorectal malformation or Hirschsprung's disease) are not being enrolled in this study.
Parents can be enrolled in the study to have an interview if they have a child who had a stoma in the last three years.
Who is organising this study?
The study is being managed by the Manchester University NHS Foundation Trust (Sponsor). The National Perinatal Epidemiology Unit Clinical Trials Unit at the University of Oxford is coordinating the study administration. Researchers at the University of Liverpool are coordinating and performing the interviews. The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.
Does taking part in this study involve any extra hospital visits, or questionnaires to fill in?
No. If your baby is enrolled in the study because they have a stoma, we will collect information about them only while they are in hospital. The doctors and nurses caring for your baby will provide this information – you won't have to fill in any questionnaires. We will stop collecting information about your baby after they leave the hospital (either to go home, or to go to one that isn't involved in the study).
The study will not involve any extra hospital visits, tests, or procedures for your baby.
If you agree to have an interview, this will take place over the phone or online (e.g. through Zoom). You will not have to travel to any in-person interview.
What will this study do with the data about participants that it collects?
Where can I get more information about the study?
- Contact the ToSCiN Coordinating Centre, at toscin@npeu.ox.ac.uk
- The charity Bliss can also provide a wide range of free services for the families of premature and sick babies, including emotional and practical support. They are supporting this research project and can be contacted via email: hello@bliss.co.uk or telephone: 020 7378 1122
