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

July 10, 2025 updated by: Charles P.B. Vanderpool, Indiana University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children at IU Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Smoflipid 20%
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.
Drug: Smoflipid 20% Lipid Emulsion for Injection
Intravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day
Experimental: Intralipid 20% Reduction
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.
Drug: Intralipid, 20% Intravenous Emulsion
Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day
Other Names:
  • Intralipid 20% Reduction
Drug: Intralipid, 20% Intravenous Emulsion
Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day
Other Names:
  • Intralipid 20% Historic
Other: Intralipid 20% Historic
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.
Drug: Intralipid, 20% Intravenous Emulsion
Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day
Other Names:
  • Intralipid 20% Reduction
Drug: Intralipid, 20% Intravenous Emulsion
Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day
Other Names:
  • Intralipid 20% Historic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Cholestasis
Time Frame: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.
Cholestasis was defined as a direct bilirubin > 2 mg/dL on two measurements 5 to 7 days apart.
Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight Velocity
Time Frame: 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.
Weight velocity was calculated as the difference in weight from end to start of study divided by number of days enrolled in study.
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.
Length Velocity
Time Frame: 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.
Length velocity was defined as the difference in length from end of study compared to enrollment divided by the number of days enrolled in study.
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.
Head Circumference (OFC) Velocity
Time Frame: OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity.
OFC velocity was calculated as difference end and start of study divided by number of days enrolled in study.
OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity.
Average Total Calorie Intake
Time Frame: Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.
Total calorie intake, including parenteral and enteral sources, were averaged on a weekly basis.
Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.
Number of Patients With Enteral Autonomy at End of Study
Time Frame: 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.
Percentage of patients with enteral autonomy at time of leaving or stopping study was calculated. Enteral autonomy was defined as relying on enteral nutrition only for nutrition intake with no need for parenteral nutrition supplementation.
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.
Number of Patients With Essential Fatty Acid Deficiency (EFAD)
Time Frame: Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.
Essential fatty acid deficiency was defined as a triene to tetraene ratio greater than 0.05.
Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.
AST Change Over Time
Time Frame: AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks.
The change of AST over time was calculated and compared between groups. AST change was calculated as AST end - AST enrollment.
AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks.
ALT Change Over Time
Time Frame: ALT measured at enrollment and every 2 weeks for max 12 weeks.
The rate of change of ALT over time was compared between groups using mixed model analysis. Change of ALT was calculated as ALT at end of study compared to ALT at enrollment.
ALT measured at enrollment and every 2 weeks for max 12 weeks.
Alkaline Phosphatase Change Over Time
Time Frame: Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks.
Alkaline phosphatase was recorded at enrollment and every 2 weeks. The change in alkaline phosphatase was calculated as alkaline phosphatase at end minus enrollment.
Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks.
Triglyceride Level Over Time
Time Frame: Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks.
All enrolled patients had serum triglyceride levels monitored at enrollment and weekly. The triglyceride level changes was calculated using values at the end of study compared to enrollment with mean and standard deviation calculated for each treatment group.
Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks.
Gamma Glutamyl Transferase (GGT) Over Time
Time Frame: GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks.
GGT was documented at baseline and regularly intervals with level compared over time between groups. GGT was compared by treatment group for levels at end of study and enrollment.
GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks.
Number of Patients With Retinopathy of Prematurity
Time Frame: Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU.
The rate of retinopathy of prematurity (ROP) was compared between groups. ROP was diagnosed based on ophthalmologist examination with all stages included.
Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU.
Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease
Time Frame: All patient had diagnosis of BPD documented from admission at level 4 NICU.
The rate of BPD was documented and compared between groups. BPD was diagnosed based on need for respiratory support at 28 days of age. All levels of severity were included.
All patient had diagnosis of BPD documented from admission at level 4 NICU.
NICU Length of Stay
Time Frame: Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU.
The length of stay at the level 4 NICU was compared between groups.
Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU.
Three Year Development- Communication
Time Frame: ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes. Scores are separated into on schedule, monitoring zone, and below cutoff. These thresholds vary by aged screened. Possible screens used for this age group include 36 months, 42 months, and 48 months dependent on exact chronologic age screen completed. At 36 months communication 45-60 is on schedule; 35-40 monitoring, and <35 below cutoff. For 42 months on schedule 40-60; monitoring 30-35; below cutoff <35. For 48 months on schedule 45-60; monitoring 35-40; below cutoff <35.
ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.
Three Year Development: Gross Motor
Time Frame: three year chronological age 3 years and 0 days to 3 years and 364 days
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcome, there are three possible scoring categories on schedule (normal), monitoring zone, below cutoff. Score thresholds by possible screens include: 36 months on schedule 50-60; monitoring 40-45; below cutoff <40. 42 months on schedule 50-60; monitoring 40-45; below cutoff <40. 48 months on schedule 45-60; monitoring 35-40; below cutoff <35.
three year chronological age 3 years and 0 days to 3 years and 364 days
Three Year Development: Fine Motor
Time Frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes with three scoring categories: on schedule (normal), monitoring zone, and below cutoff. These thresholds vary by each category and screening age. Based on the possible screens for chronological age the score categories are: 36 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff. 42 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff. 48 months: 35-60 on schedule; 20-30 monitoring; <20 below cutoff.
three year chronological age (3 years and 0 days to 3 years and 364 days)
Three Year Development: Problem Solving
Time Frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three possible score categories: on schedule (normal), monitoring zone, and below cutoff. Category thresholds vary by outcome category and age of screen. There are three possible screens that were used for this population, chosen based on chronologic age. The score categories based on age are: 36 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 42 months: 40-60 on schdule; 30-35 monitoring; <30 below cutoff. 48 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff
three year chronological age (3 years and 0 days to 3 years and 364 days)
Three Year Development: Personal Social
Time Frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three score categories possible including on schedule (normal), monitoring zone, and below cutoff. These thresholds vary based on outcome measure and age of screen completed. Screen used depends on chronological age at screen. Score thresholds for each age include: 36 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 42 months: 45-60 on schedule; 35-40 monitoring; <35 below cutoff. 48 months: 40-60 on schedule; 30-40 monitoring; <30 below cutoff.
three year chronological age (3 years and 0 days to 3 years and 364 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1708745276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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