Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.

The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.

Inclusion Criteria:

• Healthy newborn singleton infant
• Full-term (>= 37 weeks gestation)
• Birth weight between >= 2500 and < =4500 g
• 14 ± 3 days of age on enrollment
• Infant's mother has elected not to breastfeed
• baby has been exclusively formula fed a minimum of 3 days prior to enrollment
• Study explained and written information provided with Parent/Caregiver
• Informed consent signed (parent/legal representative)

Exclusion Criteria:

• Congenital illness or malformation affecting infant feeding and/or 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 enrollment
• Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment
• 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 has received probiotics in the seven days prior to enrollment
• Infant currently participating in another clinical study
• Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol