Effect of Nutritional Supplementation on Pediatric Burn Patients

September 4, 2012 updated by: Abbott Nutrition
This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Ekaterinburg, Russian Federation, 620134
        • Children City Clinical Hospital #9
      • Izhevsk, Russian Federation, 426039
        • First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
      • Kazan, Russian Federation, 420138
        • Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
      • Kemerovo, Russian Federation, 650033
        • City Clinical Hospital #2
      • Moscow, Russian Federation, 123317
        • Children's City Hospital #9
      • Nizhny Novgorod, Russian Federation, 603155
        • Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care
      • Rostov-na-Donu, Russian Federation, 344091
        • City Hospital #20
      • Saratov, Russian Federation, 410005
        • City Clinical Hospital #7
      • St. Petersburg, Russian Federation, 198205
        • Children's City Hospital #1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hospital Feed
Standard hospital food
Other: Hospital food
Typical hospital food given daily at meals
Experimental: Hospital Feed plus nutritional supplement
Standard hospital food plus nutritional supplement
Other: Nutritional Supplement
Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prealbumin
Time Frame: Change between Baseline and Day 14
Change between Baseline and Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Preablumin
Time Frame: Change between Baseline and Day 7
Change between Baseline and Day 7
C Reactive Protein (CRP)
Time Frame: Between baseline and Day 7
Between baseline and Day 7
C Reactive Protein
Time Frame: Between baseline and Day 14
Between baseline and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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