A Phase 4 interventional study of Infant formula and Breast feeding in Infant Nutrition, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged Up to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-08.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Supportive care
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
Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position
Other: Infant formula
Complete breast feed within the first 3 month
Other: Breast feeding
Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage \& frequency: Fed as need Duration: at least 3 months
Also known as: Wondersun Brand An Li Cong Infant Formula
Breast feeding
Also known as: Not relevant
Anthropometric parameters
body length, body weight, and head circumferences
Time frame: 12 weeks
Efficacy and safety
Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders
Time frame: 6 weeks
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University