NCT01583673已完成不适用
Assessment of Growth of Infants Fed an Amino Acid Based Formula
Société des Produits Nestlé (SPN)33 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 33
- 主要终点
- Weight Gain
研究概览
简要总结
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 17 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn infant
- •Full-term (>= 37 weeks gestation)
- •Birth weight between >= 2500 and < =4500 g
- •0-17 days of age on enrolment (day 0 is day of birth)
- •Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
- •Study explained and written information provided with Caregiver demonstrating understanding of the given information
- •Informed consent signed (parent/legal representative)
排除标准
- •Congenital illness or malformation that may affect infant feeding and/or normal growth
- •Suspected or known allergy to cow's milk protein
- •Significant pre-natal and/or post-natal disease
- •Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
- •Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- •Infant currently participating in another conflicting clinical study
- •Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
结局指标
主要结局
Weight Gain
时间窗: 4 months
Mean weight gain (g/day) from enrollment to 4 months of age
次要结局
- tolerance(4 months)
研究者
研究点 (33)
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