Tube Feeding in Children Having a Bone Marrow Transplant

Stem Cell Transplant Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804631
• Other study ID #: 19SH04
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2024
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Enteral 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.

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Child Health	Great Ormond Street Hospital for Children NHS Foundation Trust, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Evans J, Needle JJ, Hirani SP. Early outcomes of gastrostomy feeding in paediatric allogenic bone marrow transplantation: A retrospective cohort study. Clin Nutr ESPEN. 2019 Jun;31:71-79. doi: 10.1016/j.clnesp.2019.02.014. Epub 2019 Mar 21. — View Citation

Gonzales F, Bruno B, Alarcon Fuentes M, De Berranger E, Guimber D, Behal H, Gandemer V, Spiegel A, Sirvent A, Yakoub-Agha I, Nelken B, Duhamel A, Seguy D. Better early outcome with enteral rather than parenteral nutrition in children undergoing MAC allo-SCT. Clin Nutr. 2018 Dec;37(6 Pt A):2113-2121. doi: 10.1016/j.clnu.2017.10.005. Epub 2017 Oct 12. — View Citation

Hoffmeister PA, Storer BE, Macris PC, Carpenter PA, Baker KS. Relationship of body mass index and arm anthropometry to outcomes after pediatric allogeneic hematopoietic cell transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2013 Jul;19(7):1081-6. doi: 10.1016/j.bbmt.2013.04.017. Epub 2013 Apr 25. — View Citation

McGrath KH, Hardikar W. Gastrostomy tube use in children with cancer. Pediatr Blood Cancer. 2019 Jul;66(7):e27702. doi: 10.1002/pbc.27702. Epub 2019 Mar 11. — View Citation

Peric Z, Botti S, Stringer J, Krawczyk J, van der Werf S, van Biezen A, Aljurf M, Murray J, Liptrott S, Greenfield DM, Duarte RF, Ruutu T, Basak GW. Variability of nutritional practices in peritransplant period after allogeneic hematopoietic stem cell transplantation: a survey by the Complications and Quality of Life Working Party of the EBMT. Bone Marrow Transplant. 2018 Aug;53(8):1030-1037. doi: 10.1038/s41409-018-0137-1. Epub 2018 Mar 7. — View Citation

Trehan A, Viani K, da Cruz LB, Sagastizado SZ, Ladas EJ. The importance of enteral nutrition to prevent or treat undernutrition in children undergoing treatment for cancer. Pediatr Blood Cancer. 2020 Jun;67 Suppl 3:e28378. doi: 10.1002/pbc.28378. — View Citation

Williams-Hooker R, Adams M, Havrilla DA, Leung W, Roach RR, Mosby TT. Caregiver and health care provider preferences of nutritional support in a hematopoietic stem cell transplant unit. Pediatr Blood Cancer. 2015 Aug;62(8):1473-6. doi: 10.1002/pbc.25473. Epub 2015 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)