Infant Nutrition
Conditions
Keywords
Term-infant, sn-2 palmitic acid, infant formula
Brief summary
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
Interventions
OTHERInfant formula
Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage & frequency: Fed as need Duration: at least 3 months
OTHERBreast feeding
Breast feeding
Sponsors
Enzymotec
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric parameters | 12 weeks | body length, body weight, and head circumferences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and safety | 6 weeks | Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders |
Countries
China
Outcome results
None listed