Tube Feeding in Children Having a Bone Marrow Transplant

Completed

• Conditions: Gastrostomy; Gastrostomy Complications; Stem Cell Transplant Complications; Enteral Feeding Intolerance; Experiences, Life; Bone Marrow Disease
• Interventions: Device: Enteral feeding tubes

• Registration Number: NCT04804631
• Lead Sponsor: Institute of Child Health

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.

Study Timeline

• Study First Submitted: 2021-02-09
• Study Start: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-18
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastrostomy tube	Enteral feeding tubes	Prophylactic gastrostomy placed prior to bone marrow transplant.
Nasogastric tube	Enteral feeding tubes	Nasogastric tube placed during admission.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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.
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
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.
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
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
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
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.
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.
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
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 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

Trial Locations

Locations (1)

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom