Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants

Study Overview
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Brief Summary
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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

Official Title
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Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial

Conditions
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Infant Nutrition

Intervention / Treatment
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* Other: Infant formula
* Other: Breast feeding


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant formula<br>The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position | Other: Infant formula<br>* Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage & frequency: Fed as need Duration: at least 3 months<br>* Other names: Wondersun Brand An Li Cong Infant Formula;|
| Active Comparator: Breast feeding<br>Complete breast feed within the first 3 month | Other: Breast feeding<br>* Breast feeding<br>* Other names: Not relevant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric parameters | body length, body weight, and head circumferences | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and safety | Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Term-infant, sn-2 palmitic acid, infant formula