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

Société des Produits Nestlé (SPN)1 site in 1 country23 target enrollmentJune 15, 2018

ConditionsChildren Requiring Amino Acid-based Formula Tube Feeding Enteral Feeding Intolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Children Requiring Amino Acid-based Formula Tube Feeding
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 23
Locations: 1
Primary Endpoint: Documented indication for formula use
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

June 15, 2018

End Date

January 31, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Documented indication for formula use

Time Frame: Up to 12 months before formula switch

Medical diagnosis

Secondary Outcomes

Stool consistency(12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch)
Stool frequency(12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch)
Length/height(12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch)
Formula volume consumption(12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch)
Body weight(12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch)
Vomiting(12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch)