The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
ad lib for 1-8 days of age until 28 days of age
ad lib from 1-8 days of age until 28 days of age
ad lib from 1-8 days of age to 28 days of age
Alabama Clinical Therapeutics
Dothan, Alabama, United States
All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
Plantation, Florida, United States
The primary variable is Gastrointestinal tolerance.
Time frame: 1-28 days of age
The secondary variables are additional measures of GI tolerance and parental feedback.
Time frame: 1-28 days of age
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ad lib from 1-8 days of age until 28 days of age
ad lib from 1-8 days of age until 28 days of age
ad lib from 1-8 days of age until 28 days of age
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
North Georgia Clinical Research
Dalton, Georgia, United States
Northpoint Pediatrics, LLC
Indianapolis, Indiana, United States
Medical Associates Clinic, PC
Dubuque, Iowa, United States
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, United States
Pediatric Associates of Mount Carmel, Inc
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
...and 5 more locations