NCT01140243已完成不适用
Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital
Materna Laboratories2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年7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
- 31
- 试验地点
- 2
- 主要终点
- anthropometric
研究概览
简要总结
The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Weeks 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
- •whose mothers are unable to breast feed or have chosen not to breast feed,
- •Whose parents have signed the informed consent form.
- •Only the first among twins will be recorded for the study.
排除标准
- •Chromosomal abnormalities or congenital malformation.
- •Metabolic abnormalities.
- •Central nervous system abnormalities.
- •Severe developmental disorders.
- •GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
- •Milk allergy or intolerance.
- •Growth failure.
- •Chronic disease
结局指标
主要结局
anthropometric
时间窗: 12 weeks
anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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