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document
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 . BACKGROUND Children undergoing hematopoietic stem cell transplantation ( HSCT ) frequently require prolonged courses of parenteral nutrition ( PN ) as a consequence of gastrointestinal dysfunction related to preparative chemotherapy and radiation . PN has been associated with shorter engraftment time and decreased mortality during HSCT , however , it is also linked with complications , including infections , liver disease , and metabolic disturbances . Some of these complications may be a result of providing PN in excess of nutrient requirements . We previously described significant reductions in resting energy expenditure ( REE ) , as measured by indirect calorimetry , over the course of HSCT . We also documented a decline in mid-arm muscle area , suggesting depletion of muscle mass , while triceps skinfold , a marker of fat stores , was unchanged . These results suggested the need for further study of energy expenditure , body composition and nutritional intake in this group of high risk patients . DESIGN AND HYPOTHESIS We hypothesize that changes in body composition affect REE during HSCT , and that standard nutritional support may lead to overfeeding . We are performing a randomized controlled trial of parenteral nutrition among children undergoing allogeneic HSCT . Subjects are randomized to receive PN designed to provide 100 % of measured REE , or standard PN , i.e. , 140 % of estimated energy expenditure . The primary outcome variable is change in percent body fat . Secondary outcomes include glycemic control and frequency of infections , changes in REE and body composition . CONCLUSION This study will provide unique and comprehensive nutritional data and its results will guide nutritional therapy for children undergoing HSCT and possibly other catabolic patients .
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Intervention_Pharmacological
parenteral nutrition
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Intervention_Pharmacological
parenteral nutrition ( PN )
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Intervention_Pharmacological
parenteral nutrition
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Intervention_Physical
receive PN designed to provide 100 % of measured REE
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Intervention_Pharmacological
, or standard PN , i.e.
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Intervention_Educational
140 % of estimated energy expenditure
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Outcome_Physical
infections
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Outcome_Adverse-effects
,
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Outcome_Physical
liver disease
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Outcome_Adverse-effects
, and
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Outcome_Physical
metabolic disturbances
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Outcome_Adverse-effects
.
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Outcome_Physical
change in percent body fat .
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Outcome_Physical
glycemic control and frequency of infections , changes in REE and body composition .
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Participant_Age
children
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Participant_Condition
hematopoietic stem cell transplantation ( " PNTREE " )
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Participant_Age
Children
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Participant_Condition
hematopoietic stem cell transplantation ( HSCT )
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Participant_Age
children
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Participant_Condition
allogeneic HSCT
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Participant_Age
children
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Participant_Condition
HSCT