Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Blood Amino Acid levels and Frequency of Cholestasis in Neonates
研究概览
简要总结
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received Trophamine solution.
详细描述
Total parenteral nutrition is an essential component of the care of premature and ill infants. Prolonged parenteral nutrition is associated with complications affecting the hepatobiliary system, such as cholelithiasis, cholestasis, and steatosis. The most common of these is total parenteral nutrition-associated cholestasis (TPNAC), that occurs because of reduced bile flow from the liver into the duodenum. Cholestasis causes liver damage and in some cases, death. Infant and neonate are at particular risk for this complication. The incidence of TPNAC ranges from 7.4 to 84%.
Animal studies have implicated amino acids in the production of cholestasis; whereas studies in human neonates suggest a direct effect of amino acid infusions on the hepatocyte canalicular membrane. An appropriate amino acid solution might compensate for the metabolic immaturity of infants and perhaps reduce total parenteral nutrition associated complications such as cholestasis. Therefore, is important to compare the frequency of cholestasis and blood amino acid concentration during Primene and Trophamine use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns greater than 1500 g who enter the Intensive Care Unit and their pathology requiring total parenteral nutritional support (necrotizing enterocolitis, intestinal atresia, short bowel syndrome).
- •Gestational age greater than 30 weeks
- •Patients with normal liver function tests for their age, prior to the initiation of total parenteral nutrition.
- •Authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained
排除标准
- •Patients with acute renal failure
- •Congenital liver disease, end-stage liver disease
- •Patients with liver damage secondary to viral or bacterial infection
- •Patients with liver damage secondary to drugs
结局指标
主要结局
Blood Amino Acid levels and Frequency of Cholestasis in Neonates
时间窗: At baseline, day 7, 14, 21 and 28 of the administration of total parenteral nutrition (TPN
次要结局
未报告次要终点
研究者
María de Lourdes Barbosa Cortés
Associated Researcher
Coordinación de Investigación en Salud, Mexico