Tube Feeding in Children Having a Bone Marrow Transplant

Institute of Child Health43 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Enteral feeding tubesDEVICE

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.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 13 Years

Medical Language ↔ Plain English

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.

Locations (1)

Great Ormond Street Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Weight Z-score

Change in weight Z-score between groups. Measured using ward scales.

Time frame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)

Secondary Outcomes

Gastrostomy tube complications

Categorical reporting of the incidence of any complications occurring with the gastrostomy tube e.g. infection, dislodgement, blockage

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Overall survival

Percentage of children alive (with death from any cause) 100 days post-bone marrow transplant

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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".

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months)