NCT00937014已完成不适用
Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin
Société des Produits Nestlé (SPN)5 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2010年2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
- 180
- 试验地点
- 5
- 主要终点
- Mean weight gain
研究概览
简要总结
The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Days 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
- •Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
- •Tolerating a cows milk based formula for at least 3 days
- •Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
- •Informed consent signed (Parent/Legal representative)
- •Parent/Caregiver has a working freezer
- •Lives within 45 minutes of a study site
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 enrollment
- •Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
- •Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- •Infant currently participating in another 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
Mean weight gain
时间窗: 4 months
次要结局
- anthropometry, tolerance, morbidity, blood tests(9 months)
研究者
研究点 (5)
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