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Effect of Nutritional Supplementation on Pediatric Burn Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01464866
First received: November 1, 2011
Last updated: September 4, 2012
Last verified: November 2011
History of Changes
  Purpose

This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.


Condition Intervention Phase
Burns
 Other: Nutritional Supplement
Other: Hospital food
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Nutritional Supplementation on Pediatric Burn Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • prealbumin [ Time Frame: Change between Baseline and Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Preablumin [ Time Frame: Change between Baseline and Day 7 ] [ Designated as safety issue: No ]
  • C Reactive Protein (CRP) [ Time Frame: Between baseline and Day 7 ] [ Designated as safety issue: No ]
  • C Reactive Protein [ Time Frame: Between baseline and Day 14 ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hospital Feed
Standard hospital food
 Other: Hospital food
Typical hospital food given daily at meals
Experimental: Hospital Feed plus nutritional supplement
Standard hospital food plus nutritional supplement
 Other: Nutritional Supplement
Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464866

Locations
Russian Federation
Children City Clinical Hospital #9
Ekaterinburg, Russian Federation, 620134
First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
Izhevsk, Russian Federation, 426039
Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
Kazan, Russian Federation, 420138
City Clinical Hospital #2
Kemerovo, Russian Federation, 650033
Children's City Hospital #9
Moscow, Russian Federation, 123317
Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care
Nizhny Novgorod, Russian Federation, 603155
City Hospital #20
Rostov-na-Donu, Russian Federation, 344091
City Clinical Hospital #7
Saratov, Russian Federation, 410005
Children's City Hospital #1
St. Petersburg, Russian Federation, 198205
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Jennifer Williams, MPH Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01464866     History of Changes
Other Study ID Numbers: BK56
Study First Received: November 1, 2011
Last Updated: September 4, 2012
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013