Nutrition Support in Pediatric Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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parenteral nutrition titrated to measured REE

Group Type EXPERIMENTAL

parenteral nutrition titrated to measured REE

Intervention Type OTHER

standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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parenteral nutrition titrated to measured REE

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No