Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

Indiana University

Status and phase: Completed; Phase 3

Conditions: Cholestasis of Parenteral Nutrition

Treatments: Drug: Intralipid, 20% Intravenous Emulsion; Drug: Smoflipid 20% Lipid Emulsion for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03387579

1708745276

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 24 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Smoflipid 20%

Experimental group

Description:

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.

Treatment:

Drug: Smoflipid 20% Lipid Emulsion for Injection

Intralipid 20% Reduction

Experimental group

Description:

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.

Treatment:

Drug: Intralipid, 20% Intravenous Emulsion

Drug: Intralipid, 20% Intravenous Emulsion

Intralipid 20% Historic

Other group

Description:

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.

Treatment:

Drug: Intralipid, 20% Intravenous Emulsion

Drug: Intralipid, 20% Intravenous Emulsion