The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.
This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
394
New organic infant formula fed daily ad libitum
Commercially available organic infant formula fed daily ad libitum
SPRIM Pro
Indian Harbour Beach, Florida, United States
Weight Gain Velocity
Weight Gain Velocity (g/day)
Time frame: Study Day 1 to Study Day 112
Length
Length and Length Gain Velocity (cm)
Time frame: Study Day 1 to Study Day 112
Head Circumference
Head Circumference and Head Circumference Gain Velocity (cm)
Time frame: Study Day 1 to Study Day 112
Formula Intake
Formula Intake Volume (oz/kg/day)
Time frame: Study Day 1 to Study Day 112
Formula Intake (2)
Formula Intake Volume (oz/day)
Time frame: Study Day 1 to Study Day 112
Anthropometry Z-scores
Weight for age Z-score, Length for age Z-score, Weight for length Z-score, Head circumference for age Z-score
Time frame: Study Day 1 to Study Day 112
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