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NCT04247269 Clinical Trial

Review of Enteral Formulas in Children

Enteral Feeding Intolerance Clinical Trial

Official title:
Retrospective Review of Enteral Formulas in Medically Complex Children

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04247269
Other study ID # 19.02.US.HCN
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 21, 2020
Est. completion date June 2, 2022

Study information
Verified date April 2021
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2, 2022
Est. primary completion date June 2, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Enteral Tube Feeding
Enteral tube feeding

Locations
Country Name City State
United States Central Ohio Specialty Care Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nutrition Intake Assessment of enteral formula calorie and protein intake compared to nutrition prescription 12 months
Secondary Body weight Weight in kilograms 12 months
Secondary Length/height Length/height (based on age) in centimeters 12 months
Secondary Formula volume consumption Assessment of enteral formula volume compared to nutrition prescription 12 months
Secondary Stool frequency Number of stools reported in medical record 12 months
Secondary Ventilator status Assessment of ventilator change; extubated or continued 12 months
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