NCT01094080已完成不适用
Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 505
- 试验地点
- 4
- 主要终点
- change of weight from day 30 to day 120
研究概览
简要总结
In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.
Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy term newborn
- •gestational age between 37 and 41 weeks
- •birth weight between the 3th and 97th weight-for-age percentile according to the EURO-Growth charts
- •fully bottle-fed (at the latest with 28 days of age) or fully breast fed
- •written parental informed consent
- •Serbian nationality
排除标准
- •malformations, congenital heart defect, congenital vascular disease, severe diseases of gastrointestinal tract, kidney, liver, central nervous system and/or metabolic disease
- •intensive care during first 14 days of life
- •participation in any other clinical study intervention
- •twins, multiple birth
- •neonatal infection
- •medication and parenteral nutrition
- •metabolic disorders
- •birth-related complications
- •severe disturbances of neonatal adaption
结局指标
主要结局
change of weight from day 30 to day 120
时间窗: postnatal age 30 to 120 days
次要结局
- anthropometry(postnatal day 30, day 60, day 90, day 120 days)
- blood markers(postnatal day 30, day 60, day 90, day 120 days (120 only))
- Follow-up(4 Years of age)
- Follow-up at age 7 years with an interview regarding severe events and growth(7 years of age)
研究者
Prof. Berthold Koletzko
Prof
Ludwig-Maximilians - University of Munich
研究点 (4)
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