NCT01162798已完成不适用
Growth of Preterm Infants Consuming Formula
Société des Produits Nestlé (SPN)16 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年9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
- 150
- 试验地点
- 16
- 主要终点
- Growth
研究概览
简要总结
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.
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
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exclusively formula-fed
- •28-34 weeks GA at birth
- •Intact GI tract, tolerating full oral feeds
- •Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days
排除标准
- •Severe respiratory disease defined as needing mechanical ventilation at discharge
- •Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
- •Major congenital malformation, history of GI surgery, severe postnatal complications
- •Daily or routine diuretic use at time of discharge
- •Receiving more than 10% of daily kcals from food additives such as thickeners
- •Currently participating or having participated in another conflicting clinical trial.
结局指标
主要结局
Growth
时间窗: 4 months
weight gain assessed monthly
次要结局
- growth, tolerance, morbidity(6 months)
- Total body bone mineral content and density and body composition, protein status, and metabolic markers(corrected term and 4 months)
研究者
研究点 (16)
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