Study of Nutritional Suitability of a New Infant Formula for Term Infants

Study of Nutritional Suitability of a New Infant Formula for Term Infants

This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.

Inclusion Criteria:

• Healthy full term infant (37-42 weeks of gestational age)
• Birth weight 2,500 to 4,500 g
• Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
• Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
• Informed consent signed by parent(s)/caregiver(s)

Exclusion Criteria:

• Congenital illness or malformation that may affect infant feeding or normal growth
• Gastrointestinal disorders
• Suspected or known allergy to milk protein for formula groups
• Known food allergies in parents or siblings for formula groups
• Multiples
• Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment
• Infant participating in another clinical study
• Infant's family unable to comply with the protocol according to the investigators's assessment