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: an Open Label, Controlled Trial

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).