Status:
COMPLETED
Effect of Nutritional Supplementation on Pediatric Burn Patients
Lead Sponsor:
Abbott Nutrition
Conditions:
Burns
Eligibility:
All Genders
1-10 years
Phase:
PHASE3
Brief Summary
This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.
Eligibility Criteria
Inclusion
- 1-10 years of age
- Hospital admission within 24 hours post-burn
- At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
- Capable of exclusive oral feeding within 3 days of hospitalization
- Expected to be hospitalized at least 14 days
Exclusion
- History diabetes or stress-induced hyperglycemia
- Artificial ventilation
- Requires parenteral or enteral feeding
- IV albumin
- Drug that affects metabolism
- Receiving Dialysis
- Acutely impacted or constipated
- Consumes non-study nutritional supplement
- Allergy or intolerance to any study product ingredient
- Participating in non-Abbott approved concomitant trial
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01464866
Start Date
February 1 2010
End Date
September 1 2011
Last Update
September 6 2012
Active Locations (9)
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1
First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
Izhevsk, Russia, 426039
2
Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
Kazan', Russia, 420138
3
City Clinical Hospital #2
Kemerovo, Russia, 650033
4
Children's City Hospital #9
Moscow, Russia, 123317