INAPEN Protocol for Impact of Breakfast Improvement on the Nutritional Status of Hospitalized Patients (INcidence de l'Amélioration du Petit-déjeuner Sur l'Etat Nutritinonel Des Patients hospitalisés)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- serum transthyretin (prealbumin) concentration
研究概览
简要总结
Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving patient nutritional status include improving the characteristics of the food provided to increase both protein and calorie intake in at-risk patients that do not require enteral or parenteral nutrition. Looking at the various daily meals, the investigators considered that breakfast following the night fast would be the easiest meal to improve .
Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care
详细描述
INAPEN protocol for impact of breakfast improvement on the nutritional status of hospitalized patients (INcidence de l'Amélioration du Petit-déjeuner sur l'Etat Nutritinonel des patients hospitalisés)
Sponsored by Meaux Hospital (Centre Hospitalier de Meaux),
Financing: unrestricted grant from the French speaking society for enteral and parenteral nutrition [SFNEP: Société Francophone de nutrition entérale et parentérale].
Information provided by Meaux Hospital Center (Centre Hospitalier de Meaux) as per the protocol submitted to the SFNEP in 2009.
Purpose
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized for 8 days or more in the participant wards and capable of eating the proposed breakfast.
- •According to the current care procedure, patients receiving an information document and offered the possibility of refusal.
排除标准
- •End of life defined as an absence of curative treatment (limitation of care)
- •Enteral or parenteral nutrition
- •Need for limitations on oral nutrition (i.e. post-surgery)
结局指标
主要结局
serum transthyretin (prealbumin) concentration
时间窗: changes between D0 to D7 between the 2 cohorts
Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7
次要结局
- serum albumin concentration changes and length of stay(Changes between the 2 cohorts)