NCT01210391已完成不适用
Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.
Société des Produits Nestlé (SPN)28 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2010年11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
- 282
- 试验地点
- 28
- 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 extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Days 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn singleton infant
- •Full-term (>= 37 weeks gestation)
- •Birth weight between >= 2500 and < =4500 g
- •14 ± 3 days of age on enrollment
- •Infant's mother has elected not to breastfeed
- •baby has been exclusively formula fed a minimum of 3 days prior to enrollment
- •Study explained and written information provided with Parent/Caregiver
- •Informed consent signed (parent/legal representative)
排除标准
- •Congenital illness or malformation affecting infant feeding and/or 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 IV antibiotic therapy in the 10 days prior to enrollment
- •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 has received probiotics in the seven days prior to enrollment
- •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
Weight Gain
时间窗: 4 Months
Mean weight gain (g/day) from enrollment to 4 months of age.
次要结局
未报告次要终点
研究者
研究点 (28)
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