Status:
COMPLETED
Nutrition Support in Pediatric Stem Cell Transplantation
Lead Sponsor:
Boston Children's Hospital
Conditions:
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
6+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00115258
Start Date
January 1 2004
End Date
July 1 2009
Last Update
February 13 2013
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