New Infant Formula Supports Adequate Growth in Healthy Infants
New Infant Formula Supports Adequate Growth in Healthy Infants
The objective of the present study is to evaluate the growth, safety, and tolerance in
 healthy, term infants consuming a new to market infant formula (Formula A) and a commercially
 available infant formula (Formula B) with daily weight gain as the primary outcome. As
 secondary outcomes, the study will evaluate other growth parameters, tolerance, and safety.
This is a controlled randomized parallel assignment, masked (Participant, Care Provider,
 Investigator, Outcomes Assessor) study. Healthy infants will be assigned an Investigational
 (Formula A) experimental new milk based infant formula, or an active comparator Control
 (Formula B) Enfamil (trademark brand name) marketed milk based infant formula. The period for
 the study is 365 days (52 weeks) using repeated-measures mixed model (RMMM). Anthropometry,
 formula intake, tolerance, and stool characteristics will be assessed. Medically confirmed
 adverse events will be recorded throughout the study.
Inclusion Criteria:

 Infants will be eligible to participate if they meet all of the following conditions. At
 birth the infant must be:

 Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as
 the sole source of nutrition, will be approached for potential study enrollment

 1. Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater
 than 41 weeks, 6 days), singleton infant

 2. Have a birth weight of ≥ 2500 grams

 At the time of the baseline/enrollment visit, infants must be:

 1. Designated as healthy by a physician

 2. ≤21 days post-natal age (Date of Birth = Day 0)

 3. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World
 Health Organization (WHO) growth charts

 4. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World
 Health Organization (WHO) growth charts

 5. Head circumference for age ≥ 5th and ≤ 95th percentile for age according to
 sex-specific World Health Organization (WHO) growth charts

 6. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to
 sex-specific World Health Organization (WHO) growth charts

 7. Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment

 8. Have parent(s) or legal guardian(s) who agree to feed the study formula to the study
 subject as his/her sole source of nutrition for the duration of the study

 9. Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed
 Consent form approved by the Institutional Review Board prior to any participation in
 the study.

 Exclusion Criteria:

 Infants will be ineligible if they have any of the following conditions that are judged by
 a physician to interfere with the infant's normal growth, development, and/or tolerance to
 an infant formula:

 1. Infants showing evidence of anatomic and physiologic defects of the respiratory tract,
 or other congenital defects (as determined by the clinician)

 2. Evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or
 neurological diseases

 3. Having a maternal history with known adverse effects on the fetus and/or the newborn
 infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight
 is < 4300 g), active tuberculosis, perinatal infection,

 4. Having a family history of cow's milk protein intolerance/allergy

 5. Are an infant from a multiple birth (twin, triplet, etc.)

 6. Mothers who smoked cigarettes

 7. Mothers who used illicit drugs during pregnancy.