NCT02118935
Completed
Not Applicable
Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance
Mead Johnson Nutrition7 sites in 1 country161 target enrollmentApril 2014
ConditionsBehavioral Measures of Tolerance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Behavioral Measures of Tolerance
- Sponsor
- Mead Johnson Nutrition
- Enrollment
- 161
- Locations
- 7
- Primary Endpoint
- Sleep Measures (Amount of time awake and asleep in a 72 hour period)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Achieved Weight(14 weeks)
- Achieved Length(14 weeks)
- Achieved Head Circumference(14 weeks)
- Formula Intake(14 weeks)
- Fecal microbiome(Baseline and 112 days of age)
- Medically-confirmed Adverse Events(14 weeks)
- Salivary Cortisol levels(70 and 120 days of age)
- Temperament - Infant Behavior Questionnaire(Once at 112 days of age)
- Sleep Characteristics(14 weeks)
Study Sites (7)
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