Growth of Infants Fed an Amino Acid Infant Formula

Assessment of Growth of Infants Fed an Amino Acid Based Formula

The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.

Inclusion Criteria:

• Healthy newborn infant
• Full-term (>= 37 weeks gestation)
• Birth weight between >= 2500 and < =4500 g
• 0-17 days of age on enrolment (day 0 is day of birth)
• Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
• Study explained and written information provided with Caregiver demonstrating understanding of the given information
• Informed consent signed (parent/legal representative)

Exclusion Criteria:

• Congenital illness or malformation that may affect infant feeding and/or normal growth
• Suspected or known allergy to cow's milk protein
• Significant pre-natal and/or post-natal disease
• Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
• Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
• Infant currently participating in another conflicting clinical study
• Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol