Body Weight
Conditions
Brief summary
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.
Interventions
None listed
Sponsors
Mead Johnson Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Days to 16 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, 12-16 days of age at randomization * Term infant with birth weight of minimum of 2500 g * Solely formula fed * Signed Informed Consent and Protected Health Information
Exclusion criteria
* History of underlying metabolic or chronic disease or immunocompromised * Acute infection * Feeding difficulties or formula intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight measured on calibrated infant scale at each study visit | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Twenty-four hour recall of infant formula intake at each study visit | — | — |
| Medically-confirmed adverse events collected throughout the study period | — | — |
| Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit | — | — |
| Parental Product Assessment Questionnaire completed at Study Visit 2 | — | Assessment of physical properties of product and infant's reaction during consumption. |
| Body Length and Head Circumference measured at each study visit | — | — |
Countries
United States
Outcome results
None listed