Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Anthropometric parameters
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 >
- •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.
排除标准
- •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).
研究组 & 干预措施
Infant formula
The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position
干预措施: Infant formula (Other)
Breast feeding
Complete breast feed within the first 3 month
干预措施: Breast feeding (Other)
结局指标
主要结局
Anthropometric parameters
时间窗: 12 weeks
body length, body weight, and head circumferences
次要结局
- Efficacy and safety(6 weeks)
研究者
Yu-ming Chen
Professor
Sun Yat-sen University