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

Enteral Feeding Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497091
• Other study ID #: 17.10.US.HCN
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children Requiring Amino Acid-based Formula Tube Feeding
• Enteral Feeding Intolerance

Intervention

Other:
• Enteral Formula
Enteral Feeding with an amino acid-based formula

Locations

Country	Name	City	State
United States	Children's Center for Rehabilitation Hospital	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documented indication for formula use	Medical diagnosis	Up to 12 months before formula switch
Secondary	Body weight	Body weight in kilograms	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Secondary	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
Secondary	Formula volume consumption	Average of 7 days	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Secondary	Stool frequency	Average of 7 days	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Secondary	Stool consistency	Average of 7 days	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Secondary	Vomiting	Average of 7 days	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch