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OpenTrials
Completed

NCT Number: NCT01464866

Effect of Nutritional Supplementation on Pediatric Burn Patients

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

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Key information

Conditions

Burns Wounds and Injuries

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic, Izhevsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1-10 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

Exclusion criteria

  • 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

Treatment and study plan

Nutritional Supplement

Other

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

Hospital food

Other

Typical hospital food given daily at meals

Primary outcomes

  1. prealbumin

    Time frame: Change between Baseline and Day 14

Secondary outcomes

  1. Preablumin

    Time frame: Change between Baseline and Day 7

  2. C Reactive Protein (CRP)

    Time frame: Between baseline and Day 7

  3. C Reactive Protein

    Time frame: Between baseline and Day 14

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2011
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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