Behavioral Measures of Tolerance
Conditions
Brief summary
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.
Interventions
OTHERPreviously marketed cow's mlik-based infant formula
OTHERMarketed cow's milk-based infant formula with prebiotics
Sponsors
University of Kansas Medical Center
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Days to 35 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, 14-35 days of age at baseline * Term infant with birth weight of a minimum of 2500 grams * Solely formula-fed * Signed Informed Consent and Protected Health Information authorization
Exclusion criteria
* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised * Feeding difficulties or formula intolerance * Maternal history of illicit drug use or psychiatric disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Measures (Amount of time awake and asleep in a 72 hour period) | 14 weeks |
| Infant State (Infant behavior over a 72 hour period) | 14 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achieved Head Circumference | 14 weeks | Total head circumference gain |
| Formula Intake | 14 weeks | — |
| Fecal microbiome | Baseline and 112 days of age | — |
| Achieved Weight | 14 weeks | Total weight gain |
| Salivary Cortisol levels | 70 and 120 days of age | — |
| Temperament - Infant Behavior Questionnaire | Once at 112 days of age | — |
| Sleep Characteristics | 14 weeks | Amount of waking and sleeping, number of waking and sleep episodes |
| Medically-confirmed Adverse Events | 14 weeks | — |
| Achieved Length | 14 weeks | Total length gain |
Countries
United States
Outcome results
None listed