Effects of Specific Lipid Fractions-enriched Infant Formulae

Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months

This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.

Inclusion Criteria:

• Healthy newborn infant
• Infant is ≤14 days old on day of enrollment
• Gestational age ≥37 weeks (full term infants)
• Birth weight ≥2500 g and ≤4500 g
• Singleton birth
• Having obtained his/her parents'/legal representative's informed consent

Exclusion Criteria:

• Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
• Infant undergoing antibiotic therapy.
• Re-hospitalization for more than 2 days in the first 14 days of life.
• Parents not expected to comply with the protocol during the period of study participation.
• Infants currently participating in another trial