Clinical Experience With Numeta- Impact on Intake of Nutrients and Costs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Protein
研究概览
简要总结
The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software solutions) exact valid prescriptions for ordering parenteral nutrition solutions for premature infants are compared. Each PN solution is prescribed individually as well as with Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for calculating Numeta prescriptions was protein. The results of PN prescriptions were compared with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition solutions
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants <37 weeks gestational age
- •parenteral nutrition therapy
排除标准
- •hypersensitivity to egg, soy or peanut proteins or to any of the active substances
- •congenital abnormality of the amino acid metabolism
- •pathogenically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous
- •severe hyperglycemia
- •severe hyperlipidemia
- •severe disorders of lipid metabolism characterized by hypertriglyceridemia
结局指标
主要结局
Protein
时间窗: 6 weeks
Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations.
次要结局
- Potassium(6 weeks)
- Magnesium(6 weeks)
- Fat(6 weeks)
- Phosphorous(6 weeks)
- Energy(6 weeks)
- Sodium(6 weeks)
- Osmolarity(6 weeks)
- Carbohydrates(6 weeks)
- Calcium(6 weeks)
研究者
Nadja Haiden,MD
Assoc.Prof.MD
Medical University of Vienna