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