Clinical trial NCT03387579: Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Official title: Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholestasis of Parenteral Nutrition
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Cholestasis
timeFrame: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.
Secondary outcomes:
measure: Weight Velocity
timeFrame: 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.
measure: Length Velocity
timeFrame: 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.
measure: Head Circumference (OFC) Velocity
timeFrame: OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity.
measure: Average Total Calorie Intake
timeFrame: Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.
measure: Number of Patients With Enteral Autonomy at End of Study
timeFrame: 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.
measure: Number of Patients With Essential Fatty Acid Deficiency (EFAD)
timeFrame: Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.
measure: AST Change Over Time
timeFrame: AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks.
measure: ALT Change Over Time
timeFrame: ALT measured at enrollment and every 2 weeks for max 12 weeks.
measure: Alkaline Phosphatase Change Over Time
timeFrame: Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks.
measure: Triglyceride Level Over Time
timeFrame: Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks.
measure: Gamma Glutamyl Transferase (GGT) Over Time
timeFrame: GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks.
measure: Number of Patients With Retinopathy of Prematurity
timeFrame: Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU.
measure: Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease
timeFrame: All patient had diagnosis of BPD documented from admission at level 4 NICU.
measure: NICU Length of Stay
timeFrame: Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU.
measure: Three Year Development
timeFrame: ASQ will be completed anytime during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
Study officials:
References: