Tube Feeding in Children Having a Bone Marrow Transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nutrition Support in Pediatric Stem Cell Transplantation

NCT00115258

Hematopoietic Stem Cell Transplantation

COMPLETED PHASE3

Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

NCT03419078

Allogeneic Stem Cell Transplant Graft Versus Host Disease Hematologic Malignancy +1 more

COMPLETED

Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation

NCT00009711

Long-term Effects Secondary to Cancer Therapy in Children Pulmonary Complications

COMPLETED

Comparison of Quality of Life in Patients Undergoing More Intensive Versus Less Intensive Chemotherapy and Radiation Preceding a Bone Marrow Transplant

NCT00004994

Bone Marrow Transplantation

COMPLETED

Iron Overload in Stem Cell Transplant Recipients

NCT00806715

Iron Overload

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gastrostomy tube

Prophylactic gastrostomy placed prior to bone marrow transplant.

Enteral feeding tubes

Intervention Type 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.

Nasogastric tube

Nasogastric tube placed during admission.

Enteral feeding tubes

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No