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



Status:Active, not recruiting
Conditions:Neurology, Gastrointestinal, Nephrology, Digestive Disease
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Neurology
Healthy:No
Age Range:Any
Updated:8/24/2018
Start Date:January 2017
End Date:December 2018

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

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

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
We found this trial at
29
sites
Flushing, New York 11367
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Flushing, NY
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Cleveland, OH
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Coconut Creek, Florida 33066
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Coconut Creek, FL
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3633 West Lake Avenue
Glenview, Illinois 60026
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Glenview, IL
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Great Neck, New York 11021
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Great Neck, NY
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Gresham, Oregon 97030
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Gresham, OR
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Hollywood, Florida 33021
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Hollywood, FL
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49 Northwest 17th Street
Homestead, Florida 33030
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Homestead, FL
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Lafayette, Louisiana 70508
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Lafayette, LA
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Lakeside, Arizona 85929
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Lakeside, AZ
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Little Rock, Arkansas 72212
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Little Rock, AR
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1009 Falls Parkway
Marble Falls, Texas 78654
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Marble Falls, TX
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4720 South I-10 Service Road West
Metairie, Louisiana 70001
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Metairie, LA
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125 Northeast 8th Street
Miami, Florida 33030
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Miami, FL
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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2200 East Parrish Avenue
Owensboro, Kentucky 42303
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Owensboro, KY
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Phoenix, AZ
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2801 Capitol Avenue
Roseville, California 95661
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Roseville, CA
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Saint George, Utah 84790
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Saint George, UT
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5282 Medical Drive
San Antonio, Texas 78229
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San Antonio, TX
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1 Forestry Drive
Syracuse, New York 13210
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Syracuse, NY
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Tacoma, WA
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tucson, AZ
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4125 South Mingo Road
Tulsa, Oklahoma 74146
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Tulsa, OK
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Virginia Gardens, Florida 33166
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Virginia Gardens, FL
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West Columbia, South Carolina 29169
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West Columbia, SC
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201 East Strong Street
Wheeling, Illinois 60090
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Wheeling, IL
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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