Effect of Infant Formula Consumption on Infant Growth From 0 to 6 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Weight evolution of infants fed with infant formula
研究概览
简要总结
From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.
The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.
Even clinical studies are not required to market an infant formula, it is important to obtain objective date on infant growth. Therefore, this study proposes to evaluate the effect of the consumption of an infant formula on the growth of infants from 0 to 6 months in comparison with the growth curves of the World Health Organization (WHO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •0 to 3 weeks
- •Infants whose mothers do not wish or can not breastfeed for personal or medical reasons
- •Child followed by a general practitioner or pediatrician
- •Informed consent form signed by the legal representatives of the subject
- •Commitment of legal representatives to follow the constraints generated by the study
排除标准
- •Nursing mother
- •Infant born prematurely before 37 weeks of amenorrhea
- •Child allergic to cow's milk proteins
- •Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
- •Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
- •Incapacity for the legal representative(s) to understand or adhere to the protocol
- •Mother smoking or vapoting during pregnancy;
- •Subject involved in another clinical study or in an exclusion period from another study
- •Legal representatives deprived of liberty
- •Legal representatives in a position to judicial protection
- •Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
- •Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
- •BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
- •Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
研究组 & 干预措施
1 to 21-days old child
干预措施: Infantil formula (Other)
结局指标
主要结局
Weight evolution of infants fed with infant formula
时间窗: from 0 to 3 months
次要结局
- Weight evolution of infants fed with infant formula(from 0 to 6 months)
- Height evolution of infants fed with infant formula(from 0 to 6 months)
- Head circumference evolution of infants fed with infant formula(from 0 to 6 months)
研究者
Jean-Michel Lecerf
Professor
Institut Pasteur de Lille