Feeding Tolerance Evaluation
Not Applicable
Completed
- Conditions
- Healthy
- Interventions
- Other: infant formula
- Registration Number
- NCT02405572
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Formula 2 infant formula infant formula Formula 1 infant formula infant formula
- Primary Outcome Measures
Name Time Method stool consistency 2 weeks caregivers will document on diary records
- Secondary Outcome Measures
Name Time Method stool pattern 2 weeks caregivers will document on diary records
sleep pattern 2 weeks caregivers will document on diary records
adverse events 2 weeks assessed throughout the study
mood 2 weeks caregivers will document on diary records
formula intake 2 weeks caregivers will document on diary records
spit-up pattern 2 weeks caregivers will document on diary records
Trial Locations
- Locations (2)
Pedia Research
🇺🇸Owensboro, Kentucky, United States
Tanner Clinic
🇺🇸Layton, Utah, United States