Bone Marrow Disease, Enteral Feeding Intolerance, Experiences, Life, Gastrostomy, Gastrostomy Complications, Stem Cell Transplant Complications
Conditions
Keywords
Bone marrow transplantation, Haematopoietic stem cell transplantation, Nasogastric tube, Nutritional status
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.
Interventions
DEVICEEnteral 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.
Sponsors
National Institute for Health Research, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
Institute of Child Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Z-score | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Categorical reporting of the incidence of any complications occurring with the nasogastric tube e.g. dislodgement, blockage |
| Height Z-score | Measured monthly from admission to six months post-transplant (6 months) | Change in height Z-score between groups. Measured using ward stadiometer. |
| Body mass index (BMI) Z-score | Measured monthly from admission to six months post-transplant (6 months) | Change in BMI Z-score between groups. Weight and height will be combined to report BMI in kg/m\^2 and converted to Z-scores. |
| 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) | Change in MUAC Z-score between groups. Measured using ward measuring tape. |
| Overall survival | Measured for all children at day-100 post-transplant | Percentage of children alive (with death from any cause) 100 days post-bone marrow transplant |
| Non-relapse mortality | Measured for all children at day-100 post-transplant | Percentage of children alive (with death not caused by disease relapse) 100 days post-bone marrow transplant |
| Graft-versus-host disease grade III-IV | Measured for all children at day-100 post-transplant | Percentage of children with grade III-IV graft-versus-host disease (measured using modified Gluckberg classification) 100 days post-bone marrow transplant |
| Gastrointestinal graft-versus-host disease | Measured for all children at day-100 post-transplant | Percentage of children with gut graft-versus-host disease (measured using modified Gluckberg classification) 100 days post-bone marrow transplant |
| Fluid intake | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) | Average intake of fluid (total fluid intake and ml/kg) provided from oral, enteral and parenteral nutrition, averaged over 3-days, measured from the hospital's electronic patient records during the bone marrow transplant admission, and thereafter once the child is at home from 3-day food diaries recorded once per month. |
| 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) | Categorical reporting of the incidence of any complications occurring with the gastrostomy tube e.g. infection, dislodgement, blockage |
| Protein intake | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) | Average intake of protein (total protein intake and grams/kg) provided from oral, enteral and parenteral nutrition, averaged over 3-days, measured from the hospital's electronic patient records during the bone marrow transplant admission, and thereafter once the child is at home from 3-day food diaries recorded once per month. |
| 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) | Total number of days enteral nutrition is provided during admission for bone marrow 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) | Total number of days parenteral nutrition is provided during admission for bone marrow transplant |
| 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) | Categorical description of what the enteral feeding tube is used for. Categories include: Not in use, Nutrition only, Medicines only, Fluids only, Nutrition & medicines, Medicines & fluids, Nutrition, medicines & fluids. |
| 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) | Change in blood copper level (micromol/L) during admission for bone marrow transplant |
| 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) | Change in blood selenium level (micromol/L) during admission for bone marrow transplant |
| 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) | Change in blood zinc level (micromol/L) during admission for bone marrow transplant |
| 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) | Change in blood vitamin A level (micromol/L) during admission for bone marrow transplant |
| 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) | Change in blood vitamin E level (micromol/L) during admission for bone marrow transplant |
| Calorie intake | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) | Average intake of calories (total kcal intake and kcals/kg) provided from oral, enteral and parenteral nutrition, averaged over 3-days, measured from the hospital's electronic patient records during the bone marrow transplant admission, and thereafter once the child is at home from 3-day food diaries recorded once per month. |
Countries
United Kingdom
Outcome results
None listed