Healthy, Full-term Infants Who Are Formula-fed
Conditions
Brief summary
Prospective, double-blind, randomized study of 2 infant formulas.
Detailed description
Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.
Interventions
OTHERRoutine Infant Formula 1
Routine infant formula with probiotic
OTHERRoutine Infant Formula 2
Routine infant formula with probiotic and prebiotic
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Days to 19 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy newborn singleton infant * Full-term (\> 37 weeks gestation) * Birth weight ≥ 2500 grams and ≤ 4500 grams * 9-19 days of age on enrollment * Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment * Having obtained his/her legal representative's informed consent
Exclusion criteria
* Known or suspected cow-milk allergy * Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula * Currently not tolerating (as perceived by the caregiver) their formula * Currently being treated for reflux * Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu) * Congenital illness or malformation that may affect infant feeding and/or growth * Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment * Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted). * Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen). * Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant GI Symptom Burden | 6 weeks | Study personnel will administer questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spit-up and/or vomiting pattern | 6 weeks | Caregivers will document on diary records |
| Crying and fussing duration | 6 weeks | Caregivers will document on diary records |
| Formula intake | 6 weeks | Caregivers will document on diary records |
| Stool pattern | 6 weeks | Caregivers will document on diary records |
| Weight (measured in grams) | Enrollment and 6 weeks | Study personnel will measure |
| Length (measured in centimeters) | Enrollment and 6 weeks | Study personnel will measure |
| Adverse events | 2 weeks and 6 weeks | Assessed throughout study |
| Formula satisfaction questionnaire | 6 weeks | Study personnel will administer questionnaire |
Countries
United States
Outcome results
None listed