NCT01379417已完成不适用
Probiotics Supplementation and Nutritional Benefit in Premature Infants
Société des Produits Nestlé (SPN)6 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2007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
- 199
- 试验地点
- 6
- 主要终点
- Weight (g)
研究概览
简要总结
The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 26 weeks and 31 weeks
- •Birth weight between 700 to 1600 g
- •Eutrophic infants (weight between -2 to 2 DS, Usher curves)
- •Admitted to one of the participating hospital unit within the 8 days following the birth, the birth date equals the 1st day of life.
- •Still on parenteral feeding or infusion on the 5th day of birth
- •Non inclusion criteria
- •Digestive disorders > or equal to 1b on Bell stage
- •Severe intra-ventricular haemorrhage (stage 3-4) before 5th day of life.
- •Severe malformations or digestive malformations
- •No antenatal corticosteroid therapy
- •Severe medical or surgical disorder affecting the absorption, digesting and as a result the growth (Hirschsprung disease, lactose intolerance, cow milk protein allergy, mucoviscidosis).
- •Parents geographical distance preventing the hospitalization follow-up in the hospital participating unit (geographical distance planned before the infant reaches 1500 g or 32 weeks of gestational age)
排除标准
- •Enteral/Oral feeding termination during more than 72 hours due to severe digestive disorders (> or equal to 2a on Bell stage )
- •Serious digestive surgery
结局指标
主要结局
Weight (g)
时间窗: From 4 to 6 weeks after inclusion
次要结局
- Growth(between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period))
研究者
研究点 (6)
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