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NCT01464866 Clinical Trial

Effect of Nutritional Supplementation on Pediatric Burn Patients

Burns Clinical Trial

Official title:
Effect of Nutritional Supplementation on Pediatric Burn Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01464866
Other study ID # BK56
Secondary ID
Status Completed
Phase Phase 3
First received November 1, 2011
Last updated September 4, 2012
Start date February 2010
Est. completion date September 2011

Study information
Verified date November 2011
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date September 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 10 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Nutritional Supplement
Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.
• Hospital food
Typical hospital food given daily at meals

Locations
Country Name City State
Russian Federation Children City Clinical Hospital #9 Ekaterinburg
Russian Federation First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic Izhevsk
Russian Federation Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic Kazan
Russian Federation City Clinical Hospital #2 Kemerovo
Russian Federation Children's City Hospital #9 Moscow
Russian Federation Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care Nizhny Novgorod
Russian Federation City Hospital #20 Rostov-na-Donu
Russian Federation City Clinical Hospital #7 Saratov
Russian Federation Children's City Hospital #1 St. Petersburg

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary prealbumin Change between Baseline and Day 14 No
Secondary Preablumin Change between Baseline and Day 7 No
Secondary C Reactive Protein (CRP) Between baseline and Day 7 No
Secondary C Reactive Protein Between baseline and Day 14 No
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