Clinical trial NCT04804631: Tube Feeding in Children Having a Bone Marrow Transplant
Official title: A Mixed Methods Study Investigating Complications, Outcomes and Family Experiences of Gastrostomy Feeding in Paediatric Allogeneic Bone Marrow Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Disease
Stem Cell Transplant Complications
Enteral Feeding Intolerance
Gastrostomy
Gastrostomy Complications
Experiences, Life
Keywords: Bone marrow transplantation
Haematopoietic stem cell transplantation
Nasogastric tube
Nutritional status
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Great Ormond Street Hospital for Children NHS Foundation Trust
First posted: 2021-03-18
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children admitted to the centre over 12 months (allowing six months follow up) for an allogeneic BMT, for any diagnosis (malignant or non-malignant), planned to receive any type of conditioning and any donor type, will be eligible and vetted according to the inclusion/exclusion criteria. Children transplanted at the centre mainly come from London, but can be from other parts of the UK too, and are anywhere between a few months old up to the eldest of around 13 years.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight Z-score
timeFrame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)
Secondary outcomes:
measure: Gastrostomy tube complications
timeFrame: 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)
measure: Nasogastric tube complications
timeFrame: 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)
measure: Height Z-score
timeFrame: Measured monthly from admission to six months post-transplant (6 months)
measure: Body mass index (BMI) Z-score
timeFrame: Measured monthly from admission to six months post-transplant (6 months)
measure: Mid-upper-arm circumference (MUAC) Z-score
timeFrame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)
measure: Overall survival
timeFrame: Measured for all children at day-100 post-transplant
measure: Non-relapse mortality
timeFrame: Measured for all children at day-100 post-transplant
measure: Graft-versus-host disease grade III-IV
timeFrame: Measured for all children at day-100 post-transplant
measure: Gastrointestinal graft-versus-host disease
timeFrame: Measured for all children at day-100 post-transplant
measure: Calorie intake
timeFrame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)
measure: Protein intake
timeFrame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)
measure: Fluid intake
timeFrame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)
measure: Duration of enteral nutrition
timeFrame: Measured from admission for bone marrow transplant to tube removal or discharge home post-transplant, whichever comes first. (Hospital admission is usually 3 months)
measure: Duration of parenteral nutrition
timeFrame: Measured from admission for bone marrow transplant to tube removal or discharge home post-transplant, whichever comes first. (Hospital admission is usually 3 months)
measure: Use of enteral feeding tube
timeFrame: Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months)
measure: Blood copper level
timeFrame: Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months)
measure: Blood selenium level
timeFrame: Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months)
measure: Blood zinc level
timeFrame: Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months)
measure: Blood vitamin A level
timeFrame: Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months)
measure: Blood vitamin E level
timeFrame: Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Faith Gibson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.