Determination of Lysine Requirement in the Parenterally Fed Neonate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Oxydation of the Indicator Amino Acid L-[1-13C] phenylalanine will be measured through urine samples to determine urinary phenylalanine enrichment
研究概览
简要总结
The purpose of this study is to establish the parenteral lysine requirements for neonates.
详细描述
It is important to identify the appropriate level of lysine requirements for parenterally fed neonates as this amino acid is the limiting amino acid in the diet of neonates. Feeding lysine at requirement improves the likelihood that other amino acids will be utilized appropriately for building proteins. In addition, lysine plays a major role in calcium absorption, development of muscle proteins and in the production of hormones, enzymes and antibodies. We believe that the lysine requirement will be 158 mg/kg/day which is significantly lower than the current 267 and 327 mg/kg/d that is found in the current Trophamine and Primene parenteral solutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable neonates on TPN
- •minimum of 2.5 g/kg/d protein and 85 - 90 kcal/kg/d)
- •Post conception age of ≥ 34 weeks gestation and appropriate for gestational age
- •Weight of ≥ 1.5 kg
- •NPO or ≤10% of total protein requirement consumed enterally
排除标准
- •Infants on mechanical ventilators, supplemental oxygen or who are receiving medications that would alter protein or energy metabolism (ie. corticosteroid therapy, etc)
结局指标
主要结局
Oxydation of the Indicator Amino Acid L-[1-13C] phenylalanine will be measured through urine samples to determine urinary phenylalanine enrichment
时间窗: 2 days
次要结局
- Breath samples will be collected for the measurement of CO2 enrichment in expired air(2 days)
研究者
Karen Chapman
Clinical Research Nurse Specialist
The Hospital for Sick Children