Tube Feeding in Children Having a Bone Marrow Transplant

• ClinicalTrials.gov Identifier: NCT04804631
• Recruitment Status: Recruiting
• First Posted: March 18, 2021
• Last Update Posted: July 9, 2021
• Sponsor: Institute of Child Health
• Collaborators: National Institute for Health Research, United Kingdom; Great Ormond Street Hospital for Children NHS Foundation Trust
• Information provided by (Responsible Party): Institute of Child Health

Study Description

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.

Condition or disease	Intervention/treatment
Bone Marrow Disease; Stem Cell Transplant Complications; Enteral Feeding Intolerance; Gastrostomy; Gastrostomy Complications; Experiences, Life	Device: Enteral feeding tubes

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 Design

• Study Type: Observational
• Estimated Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Mixed Methods Study Investigating Complications, Outcomes and Family Experiences of Gastrostomy Feeding in Paediatric Allogeneic Bone Marrow Transplantation
• Actual Study Start Date: March 15, 2021
• Estimated Primary Completion Date: July 2022
• Estimated Study Completion Date: July 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Gastrostomy tube; Prophylactic gastrostomy placed prior to bone marrow transplant.	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.
Nasogastric tube; Nasogastric tube placed during admission.	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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 13 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Contacts

Contact: James Evans, MRes; 02074059200 ext 5761; james.evans@gosh.nhs.uk

Locations

United Kingdom

Great Ormond Street Hospital; Recruiting

London, United Kingdom, WC1N3JH

Contact: James Evans 02074059200 ext 5761 james.evans@gosh.nhs.uk

Sponsors and Collaborators

Institute of Child Health

National Institute for Health Research, United Kingdom

Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

• Principal Investigator: Faith Gibson, Professor; Great Ormond Street Hospital

More Information

Publications:

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.

Gonzales F, Bruno B, Alarcón 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.

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.

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. Review.

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.

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.

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.

• Responsible Party: Institute of Child Health
• ClinicalTrials.gov Identifier: NCT04804631
• Other Study ID Numbers: 19SH04
• First Posted: March 18, 2021
• Last Update Posted: July 9, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institute of Child Health:

Bone marrow transplantation; Haematopoietic stem cell transplantation; Nasogastric tube; Nutritional status

Additional relevant MeSH terms:

Bone Marrow Diseases; Hematologic Diseases