Growth of Term Infants
Conditions
Brief summary
This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.
Interventions
OTHERAn investigational infant formula containing an alternate source of DHA
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, 10-14 days of age at randomization * Term infant with birth weight of a minimum of 2500 grams * Solely formula fed * Signed Informed Consent and Protected Health Information
Exclusion criteria
* History of underlying metabolic or chronic disease or immunocompromised * Feeding difficulties or formula intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight measured at each study visit | 3.5 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body length measured at each study visit | 3.5 months | — |
| Recall of stool consistency measured at each study visit | 3.5 months | — |
| Medically-confirmed adverse events collected throughout the study period | 3.5 months | — |
| Recall of infant formula intake at each study visit | 3.5 months | — |
| Recall of gastrointestinal tolerance measured at each study visit | 3.5 months | — |
| Blood Collection | Once at 120 days of age | Blood Collection from a subset of participants to measure levels of fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA). |
| Head circumference measured at each study visit | 3.5 months | — |
Countries
United States
Outcome results
None listed