Effect of Nutritional Supplementation on Pediatric Burn Patients

Last updated: September 4, 2012
Sponsor: Abbott Nutrition
Overall Status: Completed

Phase

3

Condition

Skin Wounds

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT01464866
BK56
  • Ages 1-10
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 orhigher

  4. Capable of exclusive oral feeding within 3 days of hospitalization

  5. Expected to be hospitalized at least 14 days

Exclusion

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

Total Participants: 116
Study Start date:
February 01, 2010
Estimated Completion Date:
September 30, 2011

Connect with a study center

  • Children City Clinical Hospital #9

    Ekaterinburg, 620134
    Russian Federation

    Site Not Available

  • First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic

    Izhevsk, 426039
    Russian Federation

    Site Not Available

  • Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic

    Kazan, 420138
    Russian Federation

    Site Not Available

  • City Clinical Hospital #2

    Kemerovo, 650033
    Russian Federation

    Site Not Available

  • Children's City Hospital #9

    Moscow, 123317
    Russian Federation

    Site Not Available

  • Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care

    Nizhny Novgorod, 603155
    Russian Federation

    Site Not Available

  • City Hospital #20

    Rostov-na-Donu, 344091
    Russian Federation

    Site Not Available

  • City Clinical Hospital #7

    Saratov, 410005
    Russian Federation

    Site Not Available

  • Children's City Hospital #1

    St. Petersburg, 198205
    Russian Federation

    Site Not Available

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