Tube Feeding in Children Having a Bone Marrow Transplant

NCT04804631 | Completed

• 1 other identifier: 19SH04
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Gastrostomy tube complications

  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

  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

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

• Body mass index (BMI) Z-score

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

• Mid-upper-arm circumference (MUAC) Z-score

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

Study Arms (2)

Gastrostomy tube

Prophylactic gastrostomy placed prior to bone marrow transplant.

Device: Enteral feeding tubes

Nasogastric tube

Nasogastric tube placed during admission.

Device: Enteral feeding tubes

Interventions

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.

Gastrostomy tube; Nasogastric tube

Eligibility Criteria

• Age: 1 Month - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Child Health: lead
• National Institute for Health Research, United Kingdom: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Study Sites (1)

Great Ormond Street Hospital

London, WC1N3JH, United Kingdom

Location

Related 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.

  PMID: 31060837 BACKGROUND

• 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.

  PMID: 29097037 BACKGROUND

• 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.

  PMID: 23623893 BACKGROUND

• 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.

  PMID: 32614140 BACKGROUND

• 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.

  PMID: 30854790 BACKGROUND

• 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.

  PMID: 25809410 BACKGROUND

• 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.

  PMID: 29515252 BACKGROUND

MeSH Terms

Conditions

Bone Marrow Diseases

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Faith Gibson, Professor

  Great Ormond Street Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 18, 2021
• Study Start: March 15, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

GB (1)