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临床试验/NCT02650167
NCT02650167已完成不适用

Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Measuring caloric intake (number of days required for the calorie intake)

研究概览

简要总结

Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal circulation to the milk, and especially immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind this work is that the oro pharyngeal administration of colostrum early in preterm infants could help deliver an oral immunotherapy even before the installation of enteral nutrition, through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract. This practice would improve the digestive tolerance and the establishment of enteral feeding, the decrease in mucosal inflammatory phenomena, but also to provide any protection against subsequent infections. Finally, there could be an improvement in the secondary immune tolerance with a decrease in the occurrence of allergic phenomena.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • New premature infant with a term weight ≤ 32 weeks amenorrhea at Nice University Hospital
  • Mother seronegative for HIV

排除标准

  • Neonates with congenital pathologies immediate prenatal or neonatal diagnosis will not be included.
  • Therapy of the mother incompatible with breastfeeding during pregnancy

结局指标

主要结局

Measuring caloric intake (number of days required for the calorie intake)

时间窗: 2 days

number of days required for the calorie intake to 130 kcal / kg / day can be delivered exclusively enterally

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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