Tube Feeding in Children Having a Bone Marrow Transplant

Institute of Child Health

Status

Completed

Conditions

Bone Marrow Disease

Gastrostomy Complications

Experiences, Life

Stem Cell Transplant Complications

Gastrostomy

Enteral Feeding Intolerance

Treatments

Device: Enteral feeding tubes

Study type

Observational

Funder types

Other

Identifiers

NCT04804631

19SH04

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment

43 patients

Sex

All

Ages

1 month to 13 years old

Volunteers

No Healthy Volunteers

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.