Your Tube Study

An increasing number of children in the UK are gastrostomy fed, often for prolonged periods of time. Within this population there is growing interest among parents in using home blended diets rather than the formula feeds provided by NHS services. However there is a lack of robust research which has assessed the safety and effectiveness of a home blended diet.

Little is known about the parent’s quality of life and the cost to families of feeding a child with a gastrostomy. This study will answer these important questions and provide evidence to improve the advice and support that families receive about feeding their child with a gastrostomy.

This Research project has two parts, known as workstreams:

1. In the first workstream we will carry out what is known as qualitative research. It involves interviews with parents, children and health care professionals.These will provide important contextual information on families who feed their child through a gastrostomy to feed into the design of workstream 2. The interviews and focus groups will gather data on desired outcomes of gastrostomy feeding, variability in diets and reasons for alternate diets, their perceived benefits and safety concerns.
2. Prospective cohort of children aged 6mo > 18 years who receive most of their nutrition through a gastrostomy. Data will be collected at 0, 9 and 18 months from parents, children (if appropriate) and clinicians using standard measures and questionnaires developed specifically for the study. Examples of the types of data we will collect include: gastrointestinal symptoms, quality of life of child and parent, dietary intake, anthropometry, healthcare usage, safety outcomes and resource use (financial and time costs).

Families of children who are fed through a gastrostomy, aged 6 months to 18 years old, in England. The study will aim to recruit 300 children and their parents. Children and parents will be recruited via general, community and specialist paediatric 

Taking part will involve completing a questionnaire about your child’s gastrostomy in addition to a 4-day food diary at three different time points during an 18-month period. You will also be asked to provide permission for the research team to collect some of this information from your child’s healthcare team and NHS digital, who hold the medical records for all NHS patients.

The study has a parent advisory panel that has offered suggestions and advice at numerous stages throughout the project to date and will continue to do so going forwards.

The research team at the University of York will use your name and contact details, and your child’s name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and will oversee the quality of the study. The research team will also use these details 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 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 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 home-blended food.

We will write about the study in publications read by researchers and care providers. We will also produce a summary of the findings to share with others, including our participants. We may present the findings at events and on websites.

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.