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Total Energy Expenditure, Protein Kinetics, and Body Composition in Recovering Burn Children. (TEE)

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ClinicalTrials.gov Identifier: NCT01544868
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Kathy Prelack, PhD, RD, Shriners Hospitals for Children

Brief Summary:
The purpose of this study is to measure resting energy expenditure, total energy expenditure, and physical activity in recovering burn children to better understand their relation to impaired growth and nutritional status; and to measure whole body and muscle protein turnover during recovery from burn injury to understand their impact on body composition and energy metabolism. It also aims to look at changes in lean body mass, fat mass, bone mineral density and bone mineral content during rehabilitation and during early convalescence.

Condition or disease Intervention/treatment Phase
Energy Expenditure in Burn Children Protein Turnover in Burn Children Other: Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Total Energy Expenditure, Protein Kinetics and Body Composition During Recovery From Severe Burn Injury in Children.
Study Start Date : November 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Energy expenditure measurement
Descriptive measurements
Other: Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover
Two pre-dose urine specimens will be collected prior to an oral dose containing 0.22 g/kg total body water of 100% 18O water (or 1.2 g/kg per body weight of 10% 18O water) and 0.11 g/kg per body weight of 99.9% deuterium oxide. Then the patient will receive a single dose (4mg/kg, less than 2% of normal daily intake of 1.1g per person) of 15N glycine tracer. For this, patients will drink a dose of 15N glycine (4mg.kg 1dissolved in 20 ml of saline) mixed in 50 cc of apple juice or other liquid beverage, followed by a 50 cc wash of water. 24 hour urine collection will commence immediately. Twenty-four hour urines will be used for determining the 15N NH3 and 15N urea enrichment. Each urine container will contain 5 ml of 15N HCl for trapping the urinary ammonium. Urine will be collected each day for 3 days, for determination of the total urinary nitrogen, urea creatinine, and ammonia excretion.




Primary Outcome Measures :
  1. Total Energy Expenditure [ Time Frame: 4 years ]
    Tota Energy Expenditure will be determined in this group of burn children


Secondary Outcome Measures :
  1. Protein Turnover [ Time Frame: 4 years ]
    Protein synthesis and breakdown will determined by stable isotope methodology



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 2 less than 18 who have been admitted to our hospital for treatment of an initial wound size of 40% or greater total body surface area burn, which has subsequently healed

Exclusion Criteria:

  • hemodynamically unstable
  • not receiving enteral nutrition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544868


Locations
United States, Massachusetts
Shriners Hospitals For Chidren
Boston, Massachusetts, United States, 02446
Sponsors and Collaborators
Shriners Hospitals for Children

Responsible Party: Kathy Prelack, PhD, RD, Director of Clinical Research, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01544868     History of Changes
Other Study ID Numbers: 2006P001559
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by Kathy Prelack, PhD, RD, Shriners Hospitals for Children:
Total Energy Expenditure
Protein Balance
Burns

Additional relevant MeSH terms:
Burns
Wounds and Injuries