Tube Feeding in Children Having a Bone Marrow Transplant

Study Overview
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Brief Summary
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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
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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: Survey current nutrition practices, use and opinions towards gastrostomy tubes in UK paediatric BMT centres. Compare clinical outcomes and complications occurring from gastrostomy versus nasogastric tubes in children during BMT. Investigate decision making and experiences of families regarding tube feeding. Methods: A multiphase, convergent parallel mixed methods study across 3 work packages (WPs). 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. 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. 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.

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

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

Intervention / Treatment
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* Device: Enteral feeding tubes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastrostomy tube<br>Prophylactic gastrostomy placed prior to bone marrow transplant. | Device: Enteral feeding tubes<br>* 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.<br>|
| Nasogastric tube<br>Nasogastric tube placed during admission. | Device: Enteral feeding tubes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Z-score | Change in weight Z-score between groups. Measured using ward scales. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrostomy tube complications | Categorical reporting of the incidence of any complications occurring with the gastrostomy tube e.g. infection, dislodgement, blockage | 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 | Categorical reporting of the incidence of any complications occurring with the nasogastric tube e.g. dislodgement, blockage | 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 | Change in height Z-score between groups. Measured using ward stadiometer. | Measured monthly from admission to six months post-transplant (6 months) | 
| Body mass index (BMI) Z-score | 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. | Measured monthly from admission to six months post-transplant (6 months) | 
| Mid-upper-arm circumference (MUAC) Z-score | Change in MUAC Z-score between groups. Measured using ward measuring tape. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) | 
| Overall survival | Percentage of children alive (with death from any cause) 100 days post-bone marrow transplant | Measured for all children at day-100 post-transplant | 
| Non-relapse mortality | Percentage of children alive (with death not caused by disease relapse) 100 days post-bone marrow transplant | Measured for all children at day-100 post-transplant | 
| Graft-versus-host disease grade III-IV | Percentage of children with grade III-IV graft-versus-host disease (measured using modified Gluckberg classification) 100 days post-bone marrow transplant | Measured for all children at day-100 post-transplant | 
| Gastrointestinal graft-versus-host disease | Percentage of children with gut graft-versus-host disease (measured using modified Gluckberg classification) 100 days post-bone marrow transplant | Measured for all children at day-100 post-transplant | 
| Calorie intake | 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. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) | 
| Protein intake | 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. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) | 
| Fluid intake | 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. | 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 | Total number of days enteral nutrition is provided during admission for bone marrow transplant | Measured from admission for bone marrow transplant to tube removal or discharge home post-transplant, whichever comes first. (Hospital admission is usually 3 months) | 
| Duration of parenteral nutrition | Total number of days parenteral nutrition is provided during admission for bone marrow transplant | 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 | 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. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) | 
| Blood copper level | Change in blood copper level (micromol/L) during admission for bone marrow transplant | 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 | Change in blood selenium level (micromol/L) during admission for bone marrow transplant | Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months) | 
| Blood zinc level | Change in blood zinc level (micromol/L) during admission for bone marrow transplant | 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 | Change in blood vitamin A level (micromol/L) during admission for bone marrow transplant | 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 | Change in blood vitamin E level (micromol/L) during admission for bone marrow transplant | Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow transplantation, Haematopoietic stem cell transplantation, Nasogastric tube, Nutritional status