NCT01771588已完成不适用
Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier
Société des Produits Nestlé (SPN)22 个研究点 分布在 5 个国家目标入组 186 人开始时间: 2011年4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
- 186
- 试验地点
- 22
- 主要终点
- Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.
研究概览
简要总结
It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.
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
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
- •Male or female
- •Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
- •Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
- •Written informed consent has been obtained from the legal representative(s).
排除标准
- •Infants with current systemic disease
- •Infants with a history of systemic disease
- •Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
- •Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
- •Infants diagnosed with any inherent metabolic disease.
- •Infants diagnosed with any chromosomic disease.
- •Receiving any commercial formula supplementation to breast milk.
- •Receiving steroids at the time of enrollment.
- •Participation in another nutritional clinical trial that may affect outcomes of this study.
结局指标
主要结局
Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.
时间窗: 21 days
次要结局
未报告次要终点
研究者
研究点 (22)
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