Retrospective Review of Amino Acid Formula Use at a Children's Center

This is a retrospective review of data documented in medical records.

Study Overview

• Status: Completed
• Conditions: Enteral Feeding Intolerance; Children Requiring Amino Acid-based Formula Tube Feeding
• Intervention / Treatment: Other: Enteral Formula

Detailed Description

This is a retrospective review of data documented in medical records of patients consuming an amino-acid based enteral formula at a pediatric care facility in the United States.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73008
      • Children's Center for Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population studied retrospectively will be children in a pediatric feeding center consuming an amino acid-based enteral fomula and meeting the inclusion/ exclusion criteria.

Description

Inclusion Criteria:

• Consuming or with a history of consuming an amino acid-based formula

Exclusion Criteria:

• Medical records lacking information on consumption of an amino acid-based formula

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enteral Tube fed children; Enteral Formula	Other: Enteral Formula; Enteral Feeding with an amino acid-based formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documented indication for formula use	Medical diagnosis	Up to 12 months before formula switch

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight in kilograms	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Length/height	Length or height (based on age) in centimeters	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Formula volume consumption	Average of 7 days	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Stool frequency	Average of 7 days	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Stool consistency	Average of 7 days	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Vomiting	Average of 7 days	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 17.10.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
• product manufactured in and exported from the U.S.: No