ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Condition or disease Intervention/treatment Phase
Burns Other: Nutritional Supplement Other: Hospital food Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Nutritional Supplementation on Pediatric Burn Patients
Study Start Date : February 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. prealbumin [ Time Frame: Change between Baseline and Day 14 ]

Secondary Outcome Measures :
  1. Preablumin [ Time Frame: Change between Baseline and Day 7 ]
  2. C Reactive Protein (CRP) [ Time Frame: Between baseline and Day 7 ]
  3. C Reactive Protein [ Time Frame: Between baseline and Day 14 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01464866     History of Changes
Other Study ID Numbers: BK56
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: November 2011

Additional relevant MeSH terms:
Burns
Wounds and Injuries