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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathy Prelack, PhD, RD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01544868
First received: February 29, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention
Energy Expenditure in Burn Children
Protein Turnover in Burn Children
Other: Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Total Energy Expenditure, Protein Kinetics and Body Composition During Recovery From Severe Burn Injury in Children.

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Total Energy Expenditure [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Tota Energy Expenditure will be determined in this group of burn children


Secondary Outcome Measures:
  • Protein Turnover [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Protein synthesis and breakdown will determined by stable isotope methodology


Enrollment: 12
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544868

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

No publications provided

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
Study First Received: February 29, 2012
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Total Energy Expenditure
Protein Balance
Burns

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014