Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery

1708745276

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.

2018-11-30

2021-03-28

2024-03-01

Active (not recruiting)

Early phase I

24

Inclusion Criteria: 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. Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective patients will be randomized to one of the two treatment arms, either composite lipid containing fish oil (Smoflipid) or soy-based lipid reduction. A third arm will include retrospective patients who will act as controls and received soy-based lipid at standard dosing.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-05-23