The Role of Different Diets in Children who are Gastrostomy Fed

The study has two phases:

Phase 1 – a qualitative study

In this study, we are talking to small numbers of parents who have a child with a gastrostomy, young people with a gastrostomy, and healthcare professionals who provide nutritional care to families. Using individual interviews with families and group interviews with staff, this study will gather data on experiences and desired outcomes of gastrostomy feeding, variability in diets and reasons for this, and the perceived benefits and safety concerns of different diets.

We have now completed phase 1 and we are using the findings from this study to decide what information to collect in phase 2.

Phase 2 – a cohort (follow-up) study

This study is called a prospective cohort study, which means we will follow a group (cohort) of children and young people who are gastrostomy-fed over time. Information will be collected from parents and the NHS at the start of the study and again after 9 months and 18 months. Children will also provide information if they are able to.

Findings from phase 1 will help us to decide what information we collect in this study. It is likely to include the symptoms associated with having a gastrostomy (e.g. reflux, constipation, site infection), dietary intake and nutritional status, child and parent quality of life, and costs to the NHS and to families.

Families of children who receive most or all of their nutrition via gastrostomy are eligible to take part. Children must be at least 6 months old and no older than 18 years.

To be included in the study, families must also live in England and be supported a healthcare professional or care team based in one of the study’s participating NHS Organisations. A list of the NHS Organisations currently supporting the study can be found on the partcipating NHS organisations web page. We are also setting up new Organisations in the coming months so please get in touch with the study team if you are interested in taking part. If you think you are eligible for the study and would like to take part please visit the “Contact Us” page.

Parents of children who take part in the study will be asked to complete three study questionnaires: one at the beginning, one after 9 months and one after 18 months. Each questionnaire will include questions about their child’s gastrostomy and symptoms, their child’s and their own quality of life, and the costs and resources associated with their child’s gastrostomy feeds. Where appropriate, children will also be asked to report on their symptoms (such as stomach pain and nausea), and their quality of life.

Parents will also be asked to provide permission for the research team to collect some of this information from their child’s healthcare team and NHS digital, who hold the medical records for all NHS patients.

We are recruiting families until July 2020, and data collection will finish in 2022.

We are asking families to contact the study team if they are interested in taking part. The study email address is yourtube@york.ac.uk and the study telephone number is 01904 321347.

The study has a Study Steering Committee and a Project Advisory Panel, both of which provide ongoing advice to the study team.

The Study Steering Committee includes research, clinical and parent experts, and meets twice each year. This Committee is independent to the study team and reports to the funder.

The Project Advisory Panel includes parents and young people, and meets twice each year. Panel members also provide regular input and advice to the study team by phone and email, and have already helped to ensure we can successfully recruit families to the study and collect the right information.

If you take part, the research team at the University of York will use your name and contact details, and your child’s name to contact you about the study. We (the research team) will also use your child’s name and NHS number to make sure that relevant information about the study is recorded for their care and to collect information about your child for the study from your child’s healthcare team and NHS digital.

Individuals from the University of York and regulatory organisations may look at your child’s medical and research records to check the accuracy of the research study. The only people in the University of York who will have access to information that identifies you will be people who need to contact you to about the study or audit the data collection process. The people who analyse the information will not be able to identify you or your child, and will not be able to find out your name or contact details.

We will use the information you provide to compare the health and quality of life among children and young people who are formula fed with those who receive blended food.

We will write about the study in publications read by researchers and health professionals who care for tube-fed children, and we will also speak at conferences. The findings will help professionals and services to find the best ways to support and care for tube-fed children and young people and their families. The findings may also be interesting and important to families. We will produce a summary which will be publicly available, sending a copy to our research participants.

This information will not identify you or your child, and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

Read more on our privacy notice.