Trial Status: Closed to recruitment - in follow up
There are growing numbers of children living in England who require to be fed through a tube directly into the stomach (gastrostomy). 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. This study aims to address a research gap by assessing 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. Stage 1: Interviews of parents (n=20) of children who are gastrostomy fed, young people (n=5-10) who are gastrostomy fed, and relevant healthcare professionals (n=24-32) including paediatrician, dietitians and community nurses. We will ask participants to identify important outcomes for children with a gastrostomy (e.g. symptoms, quality of life, safety, complications) and also explore the best way to measure these outcomes in this study.
Stage 2: 300 children who are gastrostomy fed and their parents will be recruited from childrens health services and followed up for 18 months during which time the outcomes identified from stage 1 will be measured. Detailed clinical information (e.g. diagnosis, medications) will also be collected from the childs paediatrician and dietitian. The safety and risk of complications will be examined by asking parents about visits to A and E and hospital 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.