NCT04804631

Tube Feeding in Children Having a Bone Marrow Transplant

A Mixed Methods Study Investigating Complications, Outcomes and Family Experiences of Gastrostomy Feeding in Paediatric Allogeneic Bone Marrow Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Institute of Child Health · Academic / Other
• Sex: All
• Age: 1 Month – 13 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the problems and a range of nutritional and clinical outcomes that occur with two feeding tubes used by children having a bone marrow transplant. Children and parents will also be interviewed to ask about their experiences of tube feeding.

Detailed description

Background: Bone marrow transplant (BMT) is the only potentially curative treatment for children with malignant and non-malignant diseases. Chemotherapy provided during BMT causes side-effects including diarrhoea and vomiting meaning all children become unable to eat and require tube feeding. All 16 centres in the UK use a nasogastric tube. Great Ormond Street Hospital offer families a gastrostomy as an alternative. Minimal published literature exists on gastrostomies in this population. Aims: Investigate complications, outcomes and family experiences of gastrostomy tubes in paediatric BMT. Objectives: 1. Survey current nutrition practices, use and opinions towards gastrostomy tubes in UK paediatric BMT centres. 2. Compare clinical outcomes and complications occurring from gastrostomy versus nasogastric tubes in children during BMT. 3. Investigate decision making and experiences of families regarding tube feeding. Methods: A multiphase, convergent parallel mixed methods study across 3 work packages (WPs). 1. Survey: A survey will be sent to a dietitian, nurse and doctor (the staff involved in tube feeding) in each UK paediatric BMT centre. Questions will focus on nutrition practices, and current use and opinions of gastrostomies. 2. Prospective cohort study: Outcomes will be compared between children fed via gastrostomy versus nasogastric tube from admission to six months post-BMT. All children transplanted over one year at one centre will be included. Outcomes including complications occurring with both tubes, dietary intake and anthropometry will be investigated. Anticipated sample size is 9-15 children fed via gastrostomy, 30-50 via nasogastric tube. 3. Family interviews: Families from WP 2 will be invited to be interviewed at two times; on admission to discuss why they did or did not choose a gastrostomy, and one month after discharge to discuss their experience of tube feeding. Creative methods including drawing and scrapbooks will be used during children's interviews to help them articulate their thoughts. Parents will take part in semi-structured interviews.

Conditions

• Bone Marrow Disease
• Stem Cell Transplant Complications
• Enteral Feeding Intolerance
• Gastrostomy
• Gastrostomy Complications
• Experiences, Life

Interventions

Type	Name	Description
DEVICE	Enteral feeding tubes	Families within Great Ormond Street Hospital are offered the choice of two enteral feeding tubes prior to admission for bone marrow transplant. Some families choose a gastrostomy to be placed prophylactically in the weeks prior to admission, others choose a nasogastric tube to be placed during the admission.

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2021-03-18
• Last updated: 2024-04-04

Locations

1 site across 1 country: United Kingdom