Nutrition Support in Pediatric Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Nutrition Support in Pediatric Stem Cell Transplantation - A Randomized, Controlled Trial

Conditions
-----------------
Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Other: parenteral nutrition titrated to measured REE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First myeloablative allogeneic SCT using either TBI (1400 cGy) or busulfan in addition to other chemotherapeutic agents GVHD prophylaxis with a calcineurin-inhibitor and methotrexate +/- corticosteroids Matched, related or 6/6 HLA-matched unrelated SCT donor Age 6 years and older Exclusion Criteria: Age less than 6 years, or otherwise unable to comply with study procedures Underweight (body mass index (BMI) z-score <2 for age and sex) at baseline Overweight (BMI z-score >2 for age and sex) at baseline Unable or unwilling to return for day + 100 studies Previous stem cell transplant Unmatched SCT donor Current treatment for hypo- or hyperthyroidism Current insulin dependent diabetes Current use of parenteral nutrition Allergy to egg or soy products Other contraindication to parenteral nutrition at baseline

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: parenteral nutrition titrated to measured REE<br>parenteral nutrition titrated to measured REE | Other: parenteral nutrition titrated to measured REE<br> <br> |
| No Intervention: standard of care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in % body fat at baseline, day +30, and day +100. |  | day 30 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Composition, Nutrition, Parenteral, Energy Expenditure