Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/1/2019 |
| Start Date: | November 30, 2018 |
| End Date: | March 2022 |
| Contact: | Charles Vanderpool, MD |
| Email: | chavande@iu.edu |
| Phone: | 317-944-0338 |
Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery
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.
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.
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.
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.
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
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