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Effect of Nutritional Supplementation on Pediatric Burn Patients

Effect of Nutritional Supplementation on Pediatric Burn Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01464866
Enrollment
116
Registered
2011-11-04
Start date
2010-02-28
Completion date
2011-09-30
Last updated
2012-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Brief summary

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

Interventions

OTHERNutritional Supplement

Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.

OTHERHospital food

Typical hospital food given daily at meals

Sponsors

Abbott Nutrition
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
prealbuminChange between Baseline and Day 14

Secondary

MeasureTime frame
PreabluminChange between Baseline and Day 7
C Reactive Protein (CRP)Between baseline and Day 7
C Reactive ProteinBetween baseline and Day 14

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026