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| ID | Type | Description | Link |
|---|---|---|---|
| 03-11-192 |
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The purpose of this study is to determine which method of providing parenteral nutrition (complete intravenous nutrition) will provide the best nutritional and clinical results to children undergoing hematopoietic stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| parenteral nutrition titrated to measured REE | Experimental | parenteral nutrition titrated to measured REE |
|
| standard of care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parenteral nutrition titrated to measured REE | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in % body fat at baseline, day +30, and day +100. | day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition measured by DXA, BIA, and 4-site skinfolds. | baseline, day 30, and day 100 | |
| Changes in body composition from baseline to day +100. | day 100 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher P. Duggan, M.D., M.P.H. | Boston Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12816778 | Background | Duggan C, Bechard L, Donovan K, Vangel M, O'Leary A, Holmes C, Lehmann L, Guinan E. Changes in resting energy expenditure among children undergoing allogeneic stem cell transplantation. Am J Clin Nutr. 2003 Jul;78(1):104-9. doi: 10.1093/ajcn/78.1.104. | |
| 20004739 | Background | Bechard LJ, Feldman HA, Gordon C, Gura K, Sonis A, Leung K, Venick R, Guinan EC, Duggan C. A multi-center, randomized, controlled trial of parenteral nutrition titrated to resting energy expenditure in children undergoing hematopoietic stem cell transplantation ("PNTREE"): rationale and design. Contemp Clin Trials. 2010 Mar;31(2):157-64. doi: 10.1016/j.cct.2009.12.002. Epub 2010 Jan 3. |
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| Insulin resistance, defined by HOMA, at each time point. |
| baseline, day 30, and day 100 |
| Measured resting energy expenditure (REE) at each time point. | baseline, day 30, and day 100 |
| Changes in percent predicted REE between the two groups. | baseline, day 30, and day 100 |
| Correlation between body composition and measured REE. | baseline, day 30, and day 100 |
| Resumption of oral intake. | day 30 |
| 22205317 | Result | Sharma TS, Bechard LJ, Feldman HA, Venick R, Gura K, Gordon CM, Sonis A, Guinan EC, Duggan C. Effect of titrated parenteral nutrition on body composition after allogeneic hematopoietic stem cell transplantation in children: a double-blind, randomized, multicenter trial. Am J Clin Nutr. 2012 Feb;95(2):342-51. doi: 10.3945/ajcn.111.026005. Epub 2011 Dec 28. |