Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Trial Parameters
Brief Summary
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\]), if applicable) 2. Infant gestational age ≥37 completed weeks 3. Infant birth weight of ≥2.5 kg and ≤4.5 kg 4. Singleton birth 5. Infant postnatal age ≤28 days (date of birth = day 0) 6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk 7. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol Exclusion Criteria: 1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth 2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis) 3. Maternal medical conditions known to affect infant growth (e.g., untreated preec