Status:
COMPLETED
Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Lead Sponsor:
Indiana University
Conditions:
Cholestasis of Parenteral Nutrition
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03387579
Start Date
November 30 2018
End Date
March 19 2024
Last Update
July 30 2025
Active Locations (1)
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1
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202