Effect of Nutritional Supplementation on Pediatric Burn Patients

Phase 3

Completed

• Conditions: Burns
• Interventions: Other: Hospital food; Other: Nutritional Supplement

• Registration Number: NCT01464866
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-07
• Study Completion: 2011-09
• Status Verified: 2011-11
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-04
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital Feed	Hospital food	Standard hospital food
Hospital Feed plus nutritional supplement	Nutritional Supplement	Standard hospital food plus nutritional supplement

Primary Outcome Measures

Name	Time	Method
prealbumin	Change between Baseline and Day 14

Secondary Outcome Measures

Name	Time	Method
Preablumin	Change between Baseline and Day 7
C Reactive Protein (CRP)	Between baseline and Day 7
C Reactive Protein	Between baseline and Day 14

Trial Locations

Locations (9)

City Clinical Hospital #7; 🇷🇺 Saratov, Russian Federation

Children City Clinical Hospital #9; 🇷🇺 Ekaterinburg, Russian Federation

Children's City Hospital #1; 🇷🇺 St. Petersburg, Russian Federation

First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic; 🇷🇺 Izhevsk, Russian Federation

Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic; 🇷🇺 Kazan, Russian Federation

City Hospital #20; 🇷🇺 Rostov-na-Donu, Russian Federation

Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care; 🇷🇺 Nizhny Novgorod, Russian Federation

City Clinical Hospital #2; 🇷🇺 Kemerovo, Russian Federation

Children's City Hospital #9; 🇷🇺 Moscow, Russian Federation