A Prospective, Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Requiring 28 Days of Parenteral Nutrition
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 204
- 试验地点
- 13
- 主要终点
- The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample
研究概览
简要总结
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates and infants, expected to require parenteral nutrition (PN) for 28 days
- •Postmenstrual age ≥ 24 weeks
- •Birth weight ≥ 750g
- •Gastroschisis, duodenal, jejunal or ileal atresia, volvulus, spontaneous intestinal perforation or necrotizing enterocolitis (Bell's stage 2B or higher)
- •At least 80% of nutritional needs at baseline received by PN
- •Signed and dated informed consent obtained from at least one parent or legal guardian
排除标准
- •Conjugated bilirubin > 0.6 mg/dL
- •Any known pre-, intra- or posthepatic complication increasing conjugated bilirubin levels > 0.6, mg/dL during study participation
- •Suspected liver disease or liver damage based on either aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) exceeding 2.5x upper limit of normal range
- •Active bloodstream infection demonstrated by positive blood culture at screening
- •Cystic fibrosis
- •Meconium ileus
- •Serum triglyceride levels > 250 mg/dL
- •Cyanotic congenital heart defect
- •Severe renal failure with serum creatinine > 2.0 mg/dL
- •History of shock requiring vasopressors
- •Extracorporeal Membrane Oxygenation (ECMO)
- •Known inborn errors of metabolism
- •Known congenital viral infection
- •Unlikely to survive longer than 28 days
- •Known hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients
研究组 & 干预措施
Smoflipid 20%
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
干预措施: Smoflipid 20% (investigational lipid for parenteral nutrition) (Drug)
Intralipid® 20%
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
干预措施: Intralipid® 20% (Drug)
结局指标
主要结局
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample
时间窗: Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl
Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.
次要结局
- Body Weight (Change From Baseline)(Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up))
- Head Circumference (Change From Baseline)(Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up)
- Time to Full Enteral or Oral Feeds(Day 29/end of treatment, if continued: Day 85/end of treatment)
- Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)(Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment)
- Ratio of Independent Bloodstream Infections to Number of Days on Study Medication(Day 1-29 or -85 if continued + Follow-up)
- Number of Patients Who Complete PN Treatment Without Lipid Minimization(Day 1-29 or -85 if continued + Follow-up)
- Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study(Day 1-29 or -85 if continued + Follow-up)
- Body Length (Change From Baseline)(Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up)
- Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels(Day 1-29 or -85 if continued + Follow-up)
- Length of Stay in Hospital(Day 1- Follow up (7 days after end of treatment))
- Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication(Day 1-29 or -85 if continued + Follow-up)
- Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization(Day 1-29 or -85 if continued + Follow-up)
- Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First)(Day 1-29 or -85 if continued + Follow-up)
- Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)(Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment)
- Holman Index(Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment)