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

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT03497091

Collaborator

(none)

Enrollment

Location

7.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Children Requiring Amino Acid-based Formula Tube Feeding Enteral Feeding Intolerance	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 Design

Study Type:

Observational

Actual Enrollment :

23 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 15, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Enteral Tube fed children

Enteral Formula

Other: Enteral Formula

Enteral Feeding with an amino acid-based formula

Outcome Measures

Primary Outcome Measures

Documented indication for formula use [Up to 12 months before formula switch]
Medical diagnosis

Secondary Outcome Measures

Body weight [12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch]
Body weight in kilograms
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
Stool frequency [12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch]
Average of 7 days
Stool consistency [12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch]
Average of 7 days
Vomiting [12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch]
Average of 7 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Center for Rehabilitation Hospital	Oklahoma City	Oklahoma	United States	73008

Sponsors and Collaborators

Nestlé

Investigators

Study Director: Krysmaru AraujoTorres, MD, Nestlé

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT03497091

Other Study ID Numbers:

17.10.US.HCN

First Posted:

Apr 13, 2018

Last Update Posted:

Nov 19, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 19, 2019