Review of Enteral Formulas in Children

Overview

Retrospective review of nutrition enteral formula data documented in medical records.

Full Title of Study: “Retrospective Review of Enteral Formulas in Medically Complex Children”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 2, 2022

Detailed Description

This is a retrospective review to assess nutrition (calorie and protein) intake of enteral formula data documented in medical records of patients that consumed enteral tube feeding formulas at home.

Interventions

  • Other: Enteral Tube Feeding
    • Enteral tube feeding

Arms, Groups and Cohorts

  • Enteral formula standard
    • Children fed an intact protein formula
  • Enteral formula semi-elemental
    • Children fed a semi-elemental protein formula

Clinical Trial Outcome Measures

Primary Measures

  • Nutrition Intake
    • Time Frame: 12 months
    • Assessment of enteral formula calorie and protein intake compared to nutrition prescription

Secondary Measures

  • Body weight
    • Time Frame: 12 months
    • Weight in kilograms
  • Length/height
    • Time Frame: 12 months
    • Length/height (based on age) in centimeters
  • Formula volume consumption
    • Time Frame: 12 months
    • Assessment of enteral formula volume compared to nutrition prescription
  • Stool frequency
    • Time Frame: 12 months
    • Number of stools reported in medical record
  • Ventilator status
    • Time Frame: 12 months
    • Assessment of ventilator change; extubated or continued

Participating in This Clinical Trial

Inclusion Criteria

  • Minimum 12 months enteral feeding – History of enteral feeding with intact or semi-elemental formula Exclusion Criteria:

  • Medical records lacking enteral nutrition feeding use

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Société des Produits Nestlé (SPN)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Krysmaru AraujoTorres, MD, Study Director, Société des Produits Nestlé (SPN)

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