Effect of Nutritional Supplementation on Pediatric Burn Patients
NCT ID: NCT01464866
Last Updated: 2012-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2010-02-28
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hospital Feed
Standard hospital food
Hospital food
Typical hospital food given daily at meals
Hospital Feed plus nutritional supplement
Standard hospital food plus nutritional supplement
Nutritional Supplement
Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.
Interventions
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Nutritional Supplement
Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.
Hospital food
Typical hospital food given daily at meals
Eligibility Criteria
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Inclusion Criteria
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
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
1 Year
10 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Williams, MPH
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
Izhevsk, , Russia
Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
Kazan', , Russia
City Clinical Hospital #2
Kemerovo, , Russia
Children's City Hospital #9
Moscow, , Russia
Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care
Nizhny Novgorod, , Russia
City Hospital #20
Rostov-on-Don, , Russia
Children's City Hospital #1
Saint Petersburg, , Russia
City Clinical Hospital #7
Saratov, , Russia
Children City Clinical Hospital #9
Yekaterinburg, , Russia
Countries
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Other Identifiers
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BK56
Identifier Type: -
Identifier Source: org_study_id