Title: The role of different diets in children who are gastrostomy fed
Funder: Department of Health and Social Care

Abstract: There are growing numbers of children living in England who require long term gastrostomy feeding. A gastrostomy is a surgical opening through the abdomen into the stomach. A feeding device is inserted through this opening. This allows the child to be fed directly into their stomach, bypassing the mouth and throat. _x000D_ The current professional recommendations in England are that formula feeds should be used when children are fed by gastrostomy, but there are growing numbers of parents who are choosing to feed their own children a more conventional diet of home-blended foods. There is currently no good research evidence on the symptoms, quality of life or safety of this approach in comparison with formula feeds._x000D_ This study aims to assess the symptom profile (reflux, constipation, pain) and quality of life of children who are gastrostomy fed, comparing those who are formula fed and those who are predominantly fed a home-blended diet. The study will also examine the impact on parents’ quality of life and explore costs to the families and the NHS. _x000D_ The first stage of the study will interview parents of children who are gastrostomy fed, young people who are gastrostomy fed, and relevant healthcare professionals including paediatrician, dietitians and community nurses. We will ask families and professionals to identify important outcomes for children with a gastrostomy (e.g. symptoms, quality of life, safety, complications). We will also explore how we might measure these outcomes in this study and ask parents to look at and complete some existing measures to determine which ones are most appropriate. We are very aware that these children have high caring needs therefore ensuring that we can collect data in the most efficient and least time consuming way is very important._x000D_ The second phase of the study will involve identifying and recruiting around 300 children who are gastrostomy fed and their families, and measuring key outcomes identified during stage one at three time points over an 18 month period. Children and families will be recruited from a variety of paediatric clinics and other children’s services. Detailed clinical information (e.g. diagnosis, medications) will also be collected from the child’s paediatrician and dietitian. _x000D_ The safety and risk of complications will be examined by asking parents about visits to A and E and hospital for complications related to their child’s gastrostomy and also by examining hospital records. At the end of the study we will compare the different outcomes, symptoms, complications, and costs between children who are formula fed and those who are mainly fed blended food. _x000D_ A project advisory panel comprising parents, carers and if possible, young people, will be involved in all stages of the study. The panel will contribute to the development of interview questions in stage one, data collection instruments in stage two and also the practical aspects of the study (e.g. how to recruit families). They will assist with the interpretation of results and help the research team to develop information for parents and professionals at the end of the study.

Lay abstract: Background_x000D_ There are increasing numbers of children with complex health care needs that require having all, or part, of their nutritional intake via gastrostomy feeds. The recommended feed for children via gastrostomy is commercially produced formula (1). However there is a growing body of parents who are interested in and/or choosing to feed their children home-blended meals (2, 3). These parents report benefits such as improved gastro-oesphageal reflux symptoms, less constipation and less distress in their child (4). The need for further research in this area has come from a research prioritisation exercise (5), review of the literature (6) and professional organisations e.g., British Dietetic Association (1)._x000D_ Aims_x000D_ The overall research question for this two stage study is:_x000D_ What are the risks, benefits and resource implications for using home-blended food for children with gastrostomy tubes compared to currently recommended formula feeds?_x000D_ Objectives: _x000D_ 1. To identify the important outcomes of gastrostomy feeding for parents, young people and health professionals._x000D_ 2. To assess the safety of home-blended diets for children who are gastrostomy fed compared to liquid formula diets._x000D_ 3. To identify and quantify the benefits of home-blended diets compared to liquid formula diets for children who are gastrostomy fed and their parents._x000D_ 4. To identify and quantify the resources (family and statutory services) required to support home-blended diets compared to liquid formula diets._x000D_ 5. To assess whether long-term follow-up of children who are gastrostomy fed is feasible using routine data sources._x000D_ Research Plan_x000D_ Work stream 1 (objectives 1-4): a qualitative study involving young people, parents and health professionals will provide foundational evidence with regard to the design of Workstream 2 in terms of choice of outcome measures, other data to be collected, and the feasibility and acceptability of proposed data collection methods. It will gather data on desired outcomes of gastrostomy feeding, variability in diets and reasons for variation; oral feeding, (reasons for, and perceived contribution to child’s nutrition)(7); the perceived benefits of the alternative diets, and patient safety issues experienced due to gastrostomy feeding and/or the diet used. Findings from WS1 will be reviewed at a meeting with the Study Steering Committee at which final decisions will be made about outcome domains and measures to be used, other data collection requirements, and minimising respondent burden._x000D_ Work stream 2 (objectives 1-5): a cohort study of 300 children (1:2 home-blended to formula) who are gastrostomy fed and a mechanism to assess the feasibility of long term follow up using routine data._x000D_ These children and parents will be recruited via general, community and specialist paediatric services and children’s nutrition and dietetic services. Data will be collected at months 0, 9 and 18 from parents, children (if appropriate) and clinicians using standardised measures and questionnaires developed specifically for the study. Data collected will include gastrointestinal symptoms, quality of life of child and parent, dietary intake, anthropometry, healthcare usage, safety outcomes and resource use. _x000D_ Benefit and Impact_x000D_ The beneficiaries of this research will include children with complex health conditions, their families and health care professionals through providing high quality evidence on the risks and benefits of using blended diets.

Research activity codes: 6.7 PHYSICAL
Health categories: GENERIC HEALTH RELEVANCE