The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
161
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States
Norwich Pediatrics
Norwich, Connecticut, United States
Deaconess Clinic
Evansville, Indiana, United States
Universty of Kansas Medical Center
Kansas City, Kansas, United States
Sleep Measures (Amount of time awake and asleep in a 72 hour period)
Time frame: 14 weeks
Infant State (Infant behavior over a 72 hour period)
Time frame: 14 weeks
Achieved Weight
Total weight gain
Time frame: 14 weeks
Achieved Length
Total length gain
Time frame: 14 weeks
Achieved Head Circumference
Total head circumference gain
Time frame: 14 weeks
Formula Intake
Time frame: 14 weeks
Fecal microbiome
Time frame: Baseline and 112 days of age
Medically-confirmed Adverse Events
Time frame: 14 weeks
Salivary Cortisol levels
Time frame: 70 and 120 days of age
Temperament - Infant Behavior Questionnaire
Time frame: Once at 112 days of age
Sleep Characteristics
Amount of waking and sleeping, number of waking and sleep episodes
Time frame: 14 weeks
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Woburn Pediatrics
Woburn, Massachusetts, United States
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, United States
The Jackson Clinic
Jackson, Tennessee, United States