Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants With Cholestasis
研究概览
简要总结
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.
详细描述
Intestinal failure associated liver disease (IFALD) is a cholestatic liver disease associated with prolonged need for parenteral nutrition. This disease can lead to such serious complications as liver failure and need for transplantation. In the neonatal population, short bowel syndrome, due to intestinal resection, is the most common cause of intestinal failure. While the exact cause is yet to be determined, it is felt the lipid component of parenteral nutrition is a large contributor to the development of this disease. Currently, there is no standard preventative strategy to attempt to decrease the risk of IFALD in the high risk, post-surgical neonatal population. The investigators aim to complete a randomized trial comparing two possible preventative strategies. One group will receive a composite lipid containing fish oil (Smoflipid) and the other group will receive soy-based lipid at reduced dosing.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with anticipated need for parenteral nutrition (based on primary physicians opinion) for greater than or equal to four weeks and one of the following diagnoses:
- •Anatomic: Neonate with intestinal atresia, omphalocele, gastroschisis, or volvulus with or without intestinal resection.
- •Ischemic/perforation: Neonates with spontaneous intestinal perforation or necrotizing enterocolitis requiring surgical intervention.
排除标准
- •Current weight less than 750 grams
- •AST or ALT greater than 5 times the upper limit of normal within 2 weeks of enrollment
- •Direct bilirubin greater than 2 mg/dL on any consecutive measurements 5 - 7 days apart within 2 weeks of enrollment
- •Severe coagulopathy with INR greater than 95th percentile for age (>1.7 at less than 5 days of age, > 1.5 older than five days of age)
- •Culture confirmed sepsis with positive blood, urine, or CSF culture within 2 weeks of enrollment
- •Renal failure requiring dialysis
- •Cyanotic heart disease requiring prostaglandin therapy
- •Hypertriglyceridemia (greater than 250mg/dL) at time of enrollment
研究组 & 干预措施
Smoflipid 20%
Patients randomized to this arm will receive the composite fish oil lipid, Smoflipid, at standard dosing up to 3 g/kg/day. Patients will be started on a dose of 1 g/kg/day and titrated up to maximum dose. As enteral nutrition is advanced the lipid dose will be weaned per study protocol and dietary recommendations.
干预措施: Smoflipid 20% Lipid Emulsion for Injection (Drug)
Intralipid 20% Reduction
Patients randomized to this arm will receive soy-based lipid (Intralipid) at a dose of 1 g/kg/day throughout their enrollment in the study.
干预措施: Intralipid, 20% Intravenous Emulsion (Drug)
Intralipid 20% Historic
Patients who retrospectively received soy-based lipid (Intralipid) at standard dosing of 2-3 g/kg/day were eligible for inclusion. Patients in this group were matched to prospective patients based on diagnosis, gestational age, and length of lipid therapy.
干预措施: Intralipid, 20% Intravenous Emulsion (Drug)
结局指标
主要结局
Number of Participants With Cholestasis
时间窗: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.
Cholestasis was defined as a direct bilirubin \> 2 mg/dL on two measurements 5 to 7 days apart.
次要结局
- Weight Velocity(Patient weight was recorded at enrollment, weekly during time enrolled, and at end of study for up to a maximum of 12 weeks. End and enrollment weights were used to calculate velocity.)
- Length Velocity(Length was measured at enrollment, weekly during time enrolled in study, and end of study up to a maximum of 12 weeks. End and enrollment measurements were used for velocity.)
- Average Total Calorie Intake(Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.)
- Triglyceride Level Over Time(Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks.)
- Three Year Development: Gross Motor(three year chronological age 3 years and 0 days to 3 years and 364 days)
- Three Year Development: Personal Social(three year chronological age (3 years and 0 days to 3 years and 364 days))
- Head Circumference (OFC) Velocity(OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity.)
- Gamma Glutamyl Transferase (GGT) Over Time(GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks.)
- Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease(All patient had diagnosis of BPD documented from admission at level 4 NICU.)
- Three Year Development- Communication(ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.)
- Number of Patients With Retinopathy of Prematurity(Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU.)
- Three Year Development: Fine Motor(three year chronological age (3 years and 0 days to 3 years and 364 days))
- Three Year Development: Problem Solving(three year chronological age (3 years and 0 days to 3 years and 364 days))
- Number of Patients With Enteral Autonomy at End of Study(Enteral autonomy was recorded at the study end point for each individual patient. This end point was at time of stopping study lipid, discharge from hospital, or maximum of 12 weeks.)
- Number of Patients With Essential Fatty Acid Deficiency (EFAD)(Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.)
- AST Change Over Time(AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks.)
- ALT Change Over Time(ALT measured at enrollment and every 2 weeks for max 12 weeks.)
- Alkaline Phosphatase Change Over Time(Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks.)
- NICU Length of Stay(Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU.)
研究者
Charles P.B. Vanderpool
Assistant Professor of Clinical Pediatrics, Co-chair, Nutrition Support Team at Riley Hospital for Children, Medical Director, Pediatric Intestinal Rehabilitation Program
Indiana University