A Mixed Methods Study Investigating Complications, Outcomes and Family Experiences of Gastrostomy Feeding in Paediatric Allogeneic Bone Marrow Transplantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Marrow Disease
- Sponsor
- Institute of Child Health
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Weight Z-score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Admitted to the centre during the study period for an allogeneic bone marrow transplant (BMT) for any diagnosis.
- •Receiving any conditioning regimen, donor type and stem cell source.
- •Children admitted for their second or more BMT.
- •Children admitted on an established enteral tube feeding regimen.
- •NHS patients.
Exclusion Criteria
- •Children receiving first-line, prophylactic, parenteral nutrition as this is not the standard nutrition pathway of most children receiving BMT at the centre. This is usually given in specific circumstances such as children receiving cord blood transplants or those with gastrointestinal diseases.
- •Autologous BMT, including children receiving chimeric antigen receptor T-cell therapy (CAR-T).
- •No feeding tube placed and no nutrition support required from tube feeding or parenteral nutrition. Children rarely do not require any form of nutrition support.
Outcomes
Primary Outcomes
Weight Z-score
Time Frame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)
Change in weight Z-score between groups. Measured using ward scales.
Secondary Outcomes
- Non-relapse mortality(Measured for all children at day-100 post-transplant)
- Overall survival(Measured for all children at day-100 post-transplant)
- Gastrostomy tube complications(Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to tube removal or six months post-transplant, whichever comes first (6 months))
- Nasogastric tube complications(Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to tube removal or six months post-transplant, whichever comes first (6 months))
- Height Z-score(Measured monthly from admission to six months post-transplant (6 months))
- Body mass index (BMI) Z-score(Measured monthly from admission to six months post-transplant (6 months))
- Mid-upper-arm circumference (MUAC) Z-score(Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months))
- Graft-versus-host disease grade III-IV(Measured for all children at day-100 post-transplant)
- Calorie intake(Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months))
- Gastrointestinal graft-versus-host disease(Measured for all children at day-100 post-transplant)
- Duration of parenteral nutrition(Measured from admission for bone marrow transplant to tube removal or discharge home post-transplant, whichever comes first. (Hospital admission is usually 3 months))
- Blood zinc level(Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months))
- Blood vitamin A level(Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months))
- Protein intake(Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months))
- Fluid intake(Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months))
- Duration of enteral nutrition(Measured from admission for bone marrow transplant to tube removal or discharge home post-transplant, whichever comes first. (Hospital admission is usually 3 months))
- Use of enteral feeding tube(Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months))
- Blood copper level(Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months))
- Blood selenium level(Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months))
- Blood vitamin E level(Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months))