NCT02476994终止4 期
A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid (Lipid Injectable Emulsion, USP) 20% or Standard-of-Care Soybean Oil-Based Lipid Emulsion
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Essential Fatty Acid Deficiency (EFAD)
研究概览
简要总结
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF
- •Patients age <18 years
- •Patients who are able to adhere to protocol requirements
- •Patients who are expected to require PN for at least 7 days
- •Premature infants (<36 weeks of gestation) require at least 80% PN to meet nutrition requirements at study entry; full term infants and children require at least 70% PN to meet nutrition requirements at study entry
排除标准
- •Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study
- •Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
- •Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH <7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap >16 mEq/L)
- •Patients with hemodynamic instability as judged by the Investigator
- •Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
- •Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride >400 mg/dL)
- •Patients who are unable to tolerate the necessary laboratory monitoring
- •Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment
- •Patients who are enrolled in another clinical trial involving an investigational agent
- •Patients who were treated with IV lipids within 48 hours of randomization into the study
研究组 & 干预措施
Clinolipid (lipid injectable emulsion, USP) 20%
Experimental
Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.
干预措施: Clinolipid (Drug)
Intralipid 20% (lipid injectable emulsion, USP)
Active Comparator
Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.
干预措施: Intralipid (Drug)
结局指标
主要结局
Essential Fatty Acid Deficiency (EFAD)
时间窗: Up to 90 Days
Holman Index Calculation
次要结局
- Parenteral Nutrition-Associated Cholestasis (PNAC)(Up to 90 Days)
- Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2(Baseline)
- Phytosterol, Cholesterol, and Squalene Levels(Up to 90 Days)
- Vital Signs(Up to 90 Days)
- Adverse Events and Serious Adverse Events(Up to 30 Days After Subject's Last Study Treatment)
- Fatty Acid Profile(Up to 90 Days)
- Weight(Up to 90 Days)
- Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)(Up to 90 Days)
- Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake(Up to 90 Days)
- Clinical Laboratory Tests(Up to 90 Days)
研究者
研究点 (4)
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