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

Completed

• Conditions: Enteral Feeding Intolerance; Children Requiring Amino Acid-based Formula Tube Feeding
• Interventions: Other: Enteral Formula

• Registration Number: NCT03497091
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-13
• Study Start: 2018-06-15
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enteral Tube fed children	Enteral Formula	Enteral Formula

Primary Outcome Measures

Name	Time	Method
Documented indication for formula use	Up to 12 months before formula switch	Medical diagnosis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Center for Rehabilitation Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States