Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804631
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2021-02-09
Brief Title:
Tube Feeding in Children Having a Bone Marrow Transplant
Sponsor:
Institute of Child Health
Organization:
Institute of Child Health
Study Overview
Official Title:
A Mixed Methods Study Investigating Complications Outcomes and Family Experiences of Gastrostomy Feeding in Paediatric Allogeneic Bone Marrow Transplantation
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens interviews to help them articulate their thoughts Parents will take part in semi-structured interviews
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 childrens interviews to help them articulate their thoughts Parents will take part in semi-structured interviews
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None