Effect of Nutritional Supplementation on Pediatric Burn Patients
1 other identifier
interventional
116
1 country
9
Brief Summary
This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2010
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 4, 2011
CompletedSeptember 6, 2012
November 1, 2011
1.4 years
November 1, 2011
September 4, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
prealbumin
Change between Baseline and Day 14
Secondary Outcomes (3)
Preablumin
Change between Baseline and Day 7
C Reactive Protein (CRP)
Between baseline and Day 7
C Reactive Protein
Between baseline and Day 14
Study Arms (2)
Hospital Feed
ACTIVE COMPARATORStandard hospital food
Hospital Feed plus nutritional supplement
EXPERIMENTALStandard hospital food plus nutritional supplement
Interventions
Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (9)
First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
Izhevsk, 426039, Russia
Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
Kazan', 420138, Russia
City Clinical Hospital #2
Kemerovo, 650033, Russia
Children's City Hospital #9
Moscow, 123317, Russia
Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care
Nizhny Novgorod, 603155, Russia
City Hospital #20
Rostov-on-Don, 344091, Russia
Children's City Hospital #1
Saint Petersburg, 198205, Russia
City Clinical Hospital #7
Saratov, 410005, Russia
Children City Clinical Hospital #9
Yekaterinburg, 620134, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jennifer Williams, MPH
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2011
First Posted
November 4, 2011
Study Start
February 1, 2010
Primary Completion
July 1, 2011
Study Completion
September 1, 2011
Last Updated
September 6, 2012
Record last verified: 2011-11