NCT03307122
Completed
Not Applicable
Infant Formula GI Tolerance Evaluation
Société des Produits Nestlé (SPN)8 sites in 1 country79 target enrollmentSeptember 21, 2017
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy, Full-term Infants Who Are Formula-fed
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 79
- Locations
- 8
- Primary Endpoint
- Infant GI Symptom Burden
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Infant GI Symptom Burden
Time Frame: 6 weeks
Study personnel will administer questionnaire
Secondary Outcomes
- Length (measured in centimeters)(Enrollment and 6 weeks)
- Spit-up and/or vomiting pattern(6 weeks)
- Weight (measured in grams)(Enrollment and 6 weeks)
- Adverse events(2 weeks and 6 weeks)
- Formula intake(6 weeks)
- Stool pattern(6 weeks)
- Crying and fussing duration(6 weeks)
- Formula satisfaction questionnaire(6 weeks)
Study Sites (8)
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