COMPASSIONATE USE OF AN INTRAVENOUS FAT EMULSION COMPRISED OF FSIH OIL IN THE TR

在 TR 中善意地使用由 FSIH 油组成的静脉脂肪乳剂

• 批准号: 8166719
• 负责人: STEVEN A ABRAMS
• 金额: $ 1.26万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166719
• 关键词: Alkaline Phosphatase; Amino Acids; Bilirubin; Biochemical; Calories; Childhood; Cholestasis; Cirrhosis; Computer Retrieval of Information on Scientific Projects Database; Critical Illness; Development; Diet; Dose; Electrolytes; Emulsions; Enteral; Essential Fatty Acids; Fibrosis; Funding; Glucose; Grant; Hepatic; Histologic; Human; Infant; Infusion procedures; Injury; Institution; Intake; Intervention; Intestines; Intravenous; Intravenous Fat Emulsions; Length; Lipids; Lipoidosis; Low Birth Weight Infant; Macronutrients Nutrition; Malnutrition; Micronutrients; Monitor; Nutrient; Nutritional; Oils; Operative Surgical Procedures; Parenteral Nutrition; Patients; Population; Proteins; Protocols documentation; Regimen; Research; Research Personnel; Resources; Risk Factors; Safety; Secondary to; Sepsis; Serum; Source; Starvation; Steatohepatitis; Supplementation; Trace Elements; Transaminases; United States National Institutes of Health; Vitamins; Weaning; alternative treatment; base; gastrointestinal; premature; Alkaline Phosphatase; Amino Acids; Bilirubin; Biochemical; Calories; Childhood; Cholestasis; Cirrhosis; Computer Retrieval of Information on Scientific Projects Database; Critical Illness; Development; Diet; Dose; Electrolytes; Emulsions; Enteral; Essential Fatty Acids; Fibrosis; Funding; Glucose; Grant; Hepatic; Histologic; Human; Infant; Infusion procedures; Injury; Institution; Intake; Intervention; Intestines; Intravenous; Intravenous Fat Emulsions; Length; Lipids; Lipoidosis; Low Birth Weight Infant; Macronutrients Nutrition; Malnutrition; Micronutrients; Monitor; Nutrient; Nutritional; Oils; Operative Surgical Procedures; Parenteral Nutrition; Patients; Population; Proteins; Protocols documentation; Regimen; Research; Research Personnel; Resources; Risk Factors; Safety; Secondary to; Sepsis; Serum; Source; Starvation; Steatohepatitis; Supplementation; Trace Elements; Transaminases; United States National Institutes of Health; Vitamins; Weaning; alternative treatment; base; gastrointestinal; premature

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. We propose to provide an omega-6 predominant lipid infusion (Omegaven) to patients with severe parenteral nutrition associated cholestasis (conjugated bilirubin > 6) on a compassionate use basis. We will monitor for safety parameters during the maximum 5 months of intervention. The Omegaven will be intravenously infused at a dose of 1gm/kg/day until the infant is weaned from parenteral nutrition and for no longer than 5 months. This is a continuation of protocol H-21344. To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments. Parenteral nutrition (PN) provides intravenous nutritional supplementation for patients unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function. PN contains the macronutrient building blocks of the human diet in their most elemental forms (amino acids and dextrose) and is commonly administered with a lipid emulsion to avoid essential fatty acid deficiency and to provide a calorically dense source of non-protein calories. In addition, PN contains the essential micronutrients (electrolytes, trace elements, and vitamins) to provide an optimal nutritional regimen. Before the development of PN in the late 1960 s, patients with insufficient gastrointestinal absorptive function commonly died of starvation and subsequent complications of malnutrition (1, 2). Today, more than 30,000 patients are permanently dependent on parenteral nutrition for survival. However, PN continues to be associated with hepatic injury that occurs at an unpredictable rate and includes both biochemical, i.e., elevated serum aminotransferase and alkaline phosphatase, and histologic alterations such as steatosis, steatohepatitis, lipidosis, cholestasis, fibrosis, and cirrhosis (3, 4). These abnormalities, which may worsen with the duration of PN administration, is more prevalent in the pediatric population. Additional risk factors for this condition include prematurity, low birth weight, long-term use of PN, the lack of concomitant enteral intake, sepsis, and multiple operative procedures (5).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 我们建议以富有同情的使用基础为患有严重肠胃外营养相关胆汁淤积的严重肠胃营养相关胆汁淤积（共轭胆红素> 6）的患者提供omega-6主要的脂质输注（Omegaven）。我们将在干预最长5个月内监视安全参数。 omegaven将以1gm/kg/天的剂量静脉注入，直到婴儿从肠胃外营养中断奶并且不超过5个月。这是协议H-21344的延续。 为了提供一种伴有肠胃外营养（PN）相关胆汁淤积的重症婴儿的机制，以接受omegaven，以富有同情的使用情况，而没有令人满意的替代治疗方法。 肠胃外营养（PN）为无法吸收肠道长度或功能不足的足够的肠内营养的患者提供静脉营养补充。 PN包含人类饮食中最元素的形式（氨基酸和葡萄糖）的大型营养素构建区，通常用脂质乳液给药，以避免必要的脂肪酸缺乏症，并提供非蛋白质卡路里的热量致密来源。此外，PN含有必需的微量营养素（电解质，微量元素和维生素），以提供最佳的营养方案。在1960年代后期PN发展之前，胃肠道吸收功能不足的患者通常死于饥饿和随后的营养不良并发症（1，2）。如今，超过30,000名患者永久依赖肠胃外营养以生存。但是，PN继续与以无法预测的速度发生的肝损伤有关，包括生化，即血清氨基转移酶和碱性磷酸酶升高，以及脂肪变性，例如脂肪变性，例如脂肪变性，脂肪性肝炎，脂肪性，脂肪症，脂肪，胆汁疾病，纤维化，纤维化和cirrhiss（3），以及4，4）。这些异常可能随着PN给药的持续时间而恶化，在小儿人群中更为普遍。这种情况的其他风险因素包括早产，低出生体重，长期使用PN，缺乏伴随的肠内摄入量，败血症和多种手术程序（5）。