Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants
Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants
Objective: To demonstrate the well-being of Chinese term infants fed with Wondersun formula
 with high proportion of palmitic acid in the sn-2 position.

 Design & setting: A single-center, open label study. A breast fed group will serve as
 reference. The study will be conducted in Guangzhou from 2010.1~2010.12.

 Participants: 0-14 d whole formula-fed infants and whole breast-fed infants, 30 infants in
 each group. They are required to be healthy, term-infant, and with normal birth weight, and
 have no medications known to affect their growth and development.

 Intervention: The formula-fed infants will be fed Wondersun formula with high proportion of
 palmitic acid in the sn-2 position; and breast-fed groups will be fed using breast milk for
 at least 3 month.

 Outcome measures: Tolerance and efficacy will be assessed by body measurement, stool
 characteristics questionnaire, general health examination, and behavior and habit
 questionnaire at baseline (0-14d), 6 weeks and 12 weeks. Safety will also be evaluated.

 Statistical analysis: t-test, rank test and chi-square test will be used to examine the
 significance of change from baseline to follow-up visit between the formula-fed and
 breast-fed groups for effectiveness measures
Inclusion Criteria:

 -  Parental/legal guardian written informed consent.

 -  The mother had unequivocally decided not to breast-feed (for formula fed infants) or
 to breastfeed (for human milk fed infants).

 -  Term infant of Chinese origin born at 37-42 gestation weeks as determined by menstrual
 history and corroborated by prenatal Unltra-Sound (US) and/or physical examination.

 -  Birth weight appropriate for gestational age (AGA), 2500-4000g (between 10th~ 90th
 percentile of body weight at same gestation age).

 -  The infant is apparent healthy at birth and entry to study.

 -  Apgar after 5 minutes >7.

 -  Enrolled within their first 14 days after birth.

 -  The infant is a product of normal pregnancy and delivery including C-section.

 -  Patental ability to attend visits, interviews and willing to fill questionnaires.

 Exclusion Criteria:

 -  Mother health condition: (psychological of physical) or socioeconomic problems that
 may interfere with the mother's ability to take care of her infant.

 -  The infant suffers from a major congenital abnormality or chromosomal disorder with a
 clinical significance that can be detected at birth.

 -  The infant suffers/ed from a disease requiring mechanical ventilation or medication
 treatment at the first week after birth.

 -  The infant suffers from any suspected or known metabolic or physical limitations
 interfering with feeding or normal metabolism (require a special formula).

 -  The infant is a carry of HBV (HBsAb positive).