Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Great Ormond Street Hospital for Children NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
Methods: A multiphase, convergent parallel mixed methods study across 3 work packages (WPs).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastrostomy tube | Prophylactic gastrostomy placed prior to bone marrow transplant. |
| |
| Nasogastric tube | Nasogastric tube placed during admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrostomy tube complications | Categorical reporting of the incidence of any complications occurring with the gastrostomy tube e.g. infection, dislodgement, blockage | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Faith Gibson, Professor | Great Ormond Street Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital | London | WC1N3JH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31060837 | Background | 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. | |
| 29097037 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nasogastric tube complications | Categorical reporting of the incidence of any complications occurring with the nasogastric tube e.g. dislodgement, blockage | 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 | Change in height Z-score between groups. Measured using ward stadiometer. | Measured monthly from admission to six months post-transplant (6 months) |
| Body mass index (BMI) Z-score | 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. | Measured monthly from admission to six months post-transplant (6 months) |
| Mid-upper-arm circumference (MUAC) Z-score | Change in MUAC Z-score between groups. Measured using ward measuring tape. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) |
| Overall survival | Percentage of children alive (with death from any cause) 100 days post-bone marrow transplant | Measured for all children at day-100 post-transplant |
| Non-relapse mortality | Percentage of children alive (with death not caused by disease relapse) 100 days post-bone marrow transplant | Measured for all children at day-100 post-transplant |
| Graft-versus-host disease grade III-IV | Percentage of children with grade III-IV graft-versus-host disease (measured using modified Gluckberg classification) 100 days post-bone marrow transplant | Measured for all children at day-100 post-transplant |
| Gastrointestinal graft-versus-host disease | Percentage of children with gut graft-versus-host disease (measured using modified Gluckberg classification) 100 days post-bone marrow transplant | Measured for all children at day-100 post-transplant |
| Calorie intake | 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. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) |
| Protein intake | 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. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) |
| Fluid intake | 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. | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) |
| Duration of enteral nutrition | Total number of days enteral nutrition is provided during admission for bone marrow transplant | Measured from admission for bone marrow transplant to tube removal or discharge home post-transplant, whichever comes first. (Hospital admission is usually 3 months) |
| Duration of parenteral nutrition | Total number of days parenteral nutrition is provided during admission for bone marrow transplant | Measured from admission for bone marrow transplant to tube removal or discharge home post-transplant, whichever comes first. (Hospital admission is usually 3 months) |
| Use of enteral feeding tube | 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". | Measured weekly for six weeks from admission for bone marrow transplant, and monthly thereafter to six months post-transplant (6 months) |
| Blood copper level | Change in blood copper level (micromol/L) during admission for bone marrow transplant | Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months) |
| Blood selenium level | Change in blood selenium level (micromol/L) during admission for bone marrow transplant | Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months) |
| Blood zinc level | Change in blood zinc level (micromol/L) during admission for bone marrow transplant | Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months) |
| Blood vitamin A level | Change in blood vitamin A level (micromol/L) during admission for bone marrow transplant | Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months) |
| Blood vitamin E level | Change in blood vitamin E level (micromol/L) during admission for bone marrow transplant | Measured monthly from admission for bone marrow transplant until the child is discharged home following the transplant (hospital admission is usually 3 months) |
| 23623893 | 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. |
| 32614140 | 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. |
| 30854790 | 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. |
| 25809410 | 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. |
| 29515252 | 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. |