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Trial record 91 of 365 for:    transthyretin

Effect of Nutritional Supplementation on Pediatric Burn Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01464866
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Tracking Information
First Submitted Date  ICMJE November 1, 2011
First Posted Date  ICMJE November 4, 2011
Last Update Posted Date September 6, 2012
Study Start Date  ICMJE February 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
prealbumin [ Time Frame: Change between Baseline and Day 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01464866 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2011)
  • Preablumin [ Time Frame: Change between Baseline and Day 7 ]
  • C Reactive Protein (CRP) [ Time Frame: Between baseline and Day 7 ]
  • C Reactive Protein [ Time Frame: Between baseline and Day 14 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
  • Preablumin [ Time Frame: Change between Baseline and Day 7 ]
  • CRP [ Time Frame: Between baseline and Day 7 ]
  • CRP [ Time Frame: Between baseline and Day 14 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Nutritional Supplementation on Pediatric Burn Patients
Official Title  ICMJE Effect of Nutritional Supplementation on Pediatric Burn Patients
Brief Summary This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burns
Intervention  ICMJE
  • Other: Nutritional Supplement
    Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.
  • Other: Hospital food
    Typical hospital food given daily at meals
Study Arms  ICMJE
  • Active Comparator: Hospital Feed
    Standard hospital food
    Intervention: Other: Hospital food
  • Experimental: Hospital Feed plus nutritional supplement
    Standard hospital food plus nutritional supplement
    Intervention: Other: Nutritional Supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2012)
116
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2011)
78
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 1-10 years of age
  2. Hospital admission within 24 hours post-burn
  3. At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
  4. Capable of exclusive oral feeding within 3 days of hospitalization
  5. Expected to be hospitalized at least 14 days

Exclusion Criteria:

  1. History diabetes or stress-induced hyperglycemia
  2. Artificial ventilation
  3. Requires parenteral or enteral feeding
  4. IV albumin
  5. Drug that affects metabolism
  6. Receiving Dialysis
  7. Acutely impacted or constipated
  8. Consumes non-study nutritional supplement
  9. Allergy or intolerance to any study product ingredient
  10. Participating in non-Abbott approved concomitant trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01464866
Other Study ID Numbers  ICMJE BK56
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Nutrition
Study Sponsor  ICMJE Abbott Nutrition
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jennifer Williams, MPH Abbott Nutrition
PRS Account Abbott Nutrition
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP