Effect of Nutritional Supplementation on Pediatric Burn Patients

Abbott

Status and phase: Completed; Phase 3

Conditions: Burns

Treatments: Other: Nutritional Supplement; Other: Hospital food

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464866

BK56

Details and patient eligibility

About

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

Enrollment: 116 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Hospital Feed

Active Comparator group

Description:

Standard hospital food

Treatment:

Other: Hospital food

Hospital Feed plus nutritional supplement

Experimental group

Description:

Standard hospital food plus nutritional supplement

Treatment:

Other: Nutritional Supplement