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NCT02953223 Clinical Trial

A Study to Monitor the Use of an Amino Acid-Based Infant Formula

Short Bowel Syndrome Clinical Trial

— EAGLE  

Official title:
A Study to Monitor the Use of an Amino Acid-Based Infant Formula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02953223
Other study ID # 15.04.US.HCN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date January 2019

Study information
Verified date February 2020
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

Description:

Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula

Recruitment information / eligibility
Status Completed
Enrollment 144
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility Inclusion Criteria:

- Infants who use a free amino acid based Infant formula during their first year of life including:

- Those that are currently consuming the formula at the time of enrollment

- Those for whom consumption of the formula is planned

- At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program

Exclusion Criteria:

- Infants <37 weeks of corrected gestation age (CGA) at time of enrollment

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Free amino acid infant formula
Patients who will be fed a free amino acid based infant formula

Locations
Country Name City State
United States UH Rainbow Babies & Children's Hospital Cleveland Ohio
United States Pioneer Clinical Research Coconut Creek Florida
United States Duke University Durham North Carolina
United States Conduct Clinical Trials Flushing New York
United States Children's Gastroenterology Speciality Glenview Illinois
United States The Feinstein Institute for Medical Research Great Neck New York
United States Cyn3rgy Research Gresham Oregon
United States Children's Center for GI and Nutrition Hollywood Florida
United States Childerns Health Center, PA Homestead Florida
United States Acadiana Pediatric Gastro and Hep Lafayette Louisiana
United States Pediatric Multicare West Lakeside Arizona
United States Applied Research Center of Arkansas Little Rock Arkansas
United States Childrens Health Center, PA Marble Falls Texas
United States Tulane University Health Sciences Center Metairie Louisiana
United States Homestead Medical Clinic Miami Florida
United States University of Oklahoma, Health Sciences Center Oklahoma City Oklahoma
United States Springs Medical Research Owensboro Kentucky
United States Phoenix Children's Hospital Phoenix Arizona
United States Sutter Institute of Medical Research Roseville California
United States Dixie Pediatrics Saint George Utah
United States Southwest Children's Research Assoicaites San Antonio Texas
United States State University of New York (SUNY) Syracuse New York
United States Multicare Institute for research and Innovation Tacoma Washington
United States University of Arizona Tucson Arizona
United States Milestones Pediatric Care Tulsa Oklahoma
United States Next Phase Research Virginia Gardens Florida
United States Invocare Clinical Research Center West Columbia South Carolina
United States Childrens Health Care Wheeling Illinois
United States Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula 4 months
Secondary Clinical characteristics To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula 4 months
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