Nutrition Support in Pediatric Stem Cell Transplantation

Boston Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Other: parenteral nutrition titrated to measured REE

Study type: Interventional

Funder types: Other

Identifiers

NCT00115258

03-11-192

86483

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups

parenteral nutrition titrated to measured REE

Experimental group

Description:

parenteral nutrition titrated to measured REE

Treatment:

Other: parenteral nutrition titrated to measured REE

standard of care

No Intervention group