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Completed

NCT Number: NCT04804631

Tube Feeding in Children Having a Bone Marrow Transplant

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.

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Key information

Conditions

Bone Marrow Disease Bone Marrow Diseases Enteral Feeding Intolerance Experiences, Life Gastrostomy Gastrostomy Complications Hematologic Diseases Hemic and Lymphatic Diseases Stem Cell Transplant Complications

Age range

1 month–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Great Ormond Street Hospital

London, WC1N3JH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enteral feeding tubes

Device

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.

Primary outcomes

  1. 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

  1. Gastrostomy tube complications

    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)

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

  2. Nasogastric tube complications

    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)

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

  3. Height Z-score

    Time frame: Measured monthly from admission to six months post-transplant (6 months)

    Change in height Z-score between groups. Measured using ward stadiometer.

  4. Body mass index (BMI) Z-score

    Time frame: 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.

  5. Mid-upper-arm circumference (MUAC) 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 MUAC Z-score between groups. Measured using ward measuring tape.

  6. Overall survival

    Time frame: Measured for all children at day-100 post-transplant

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

  7. Non-relapse mortality

    Time frame: 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

  8. Graft-versus-host disease grade III-IV

    Time frame: 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

  9. Gastrointestinal graft-versus-host disease

    Time frame: 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

  10. Calorie intake

    Time frame: 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.

  11. Protein intake

    Time frame: 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.

  12. Fluid intake

    Time frame: 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.

  13. Duration of enteral nutrition

    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)

    Total number of days enteral nutrition is provided during admission for bone marrow transplant

  14. Duration of parenteral nutrition

    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)

    Total number of days parenteral nutrition is provided during admission for bone marrow transplant

  15. Use of enteral feeding tube

    Time frame: 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".

  16. Blood copper level

    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)

    Change in blood copper level (micromol/L) during admission for bone marrow transplant

  17. Blood selenium level

    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)

    Change in blood selenium level (micromol/L) during admission for bone marrow transplant

  18. Blood zinc level

    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)

    Change in blood zinc level (micromol/L) during admission for bone marrow transplant

  19. Blood vitamin A level

    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)

    Change in blood vitamin A level (micromol/L) during admission for bone marrow transplant

  20. Blood vitamin E level

    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)

    Change in blood vitamin E level (micromol/L) during admission for bone marrow transplant

Sponsors and collaborators

Lead sponsor

Institute of Child Health

Other

Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust
  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2021
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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