The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
189
Ready to feed infant formula, feed ad libitum
Ready to feed infant formula, feed ad libitum
Human milk, breast feeding ad libitum
Watching Over Mothers & Babies
Tucson, Arizona, United States
Pediatric Medical Associates
Sacramento, California, United States
Weight
Weight gain per day
Time frame: Day of life 14 - 119
Stool Characteristics
Parent completed diary
Time frame: Study Day 1 to Day of life 119
Formula Tolerance
Parent completed diary
Time frame: Study Day 1 to Day of life 119
Length
Length gain per day
Time frame: Study Day 1 to Day of life 119
Head Circumference (HC)
HC gain per day
Time frame: Study Day 1 to Day of life 119
Illness Incidence
Parent reported incidence of illness
Time frame: Study Day 1 to Day of life 119
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Norwich Pediatric Group, P.C.
Norwich, Connecticut, United States
Phoenix Medical Research LLC
Miami, Florida, United States
University Clinical Research-Deland, LLC a/b/a Accel Clinical Research
Orlando, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, United States
Springs Medical Research
Owensboro, Kentucky, United States
Institute of Clinical Research, LLC
Mentor, Ohio, United States
...and 9 more locations