Healthy
Conditions
Keywords
formula-fed, infants
Brief summary
Crossover study of 2 infant formulas
Detailed description
Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.
Interventions
OTHERinfant formula
infant formulas
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy newborn infant * Full-term (\> 37 weeks gestation) * 0-2 months (birth-56 days) of age on enrollment * Infant exclusively formula-fed for at least 2 days prior to enrollment * Having obtained his/her legal representative's informed consent
Exclusion criteria
* Known or suspected cow-milk allergy * Congenital illness or malformation * Significant prenatal and/or postnatal disease * Currently participating in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stool consistency | 2 weeks | caregivers will document on diary records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| formula intake | 2 weeks | caregivers will document on diary records |
| adverse events | 2 weeks | assessed throughout the study |
| spit-up pattern | 2 weeks | caregivers will document on diary records |
| mood | 2 weeks | caregivers will document on diary records |
| sleep pattern | 2 weeks | caregivers will document on diary records |
| stool pattern | 2 weeks | caregivers will document on diary records |
Countries
United States
Outcome results
None listed