Review of Enteral Formulas in Children

June 7, 2022 updated by: Nestlé

Retrospective Review of Enteral Formulas in Medically Complex Children

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43228
        • Central Ohio Specialty Care

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 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population studied retrospectively will be children with a history of enteral tube feeding in a home setting and meeting inclusion/exclusion criteria

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enteral formula standard
Children fed an intact protein formula
Other: Enteral Tube Feeding
Enteral tube feeding
Enteral formula semi-elemental
Children fed a semi-elemental protein formula
Other: Enteral Tube Feeding
Enteral tube feeding

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Nestlé

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 (ACTUAL)

August 21, 2020

Primary Completion (ACTUAL)

June 2, 2022

Study Completion (ACTUAL)

June 2, 2022

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (ACTUAL)

January 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.02.US.HCN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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