Trial Outcomes & Findings for Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates (NCT NCT03387579)

NCT ID: NCT03387579

Last Updated: 2025-07-30

Results Overview

Cholestasis was defined as a direct bilirubin \> 2 mg/dL on two measurements 5 to 7 days apart.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 24 participants
• Primary outcome timeframe: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.
• Results posted on: 2025-07-30

Participant Flow

Patients were eligible for enrollment if they were admitted to the level IV NICU, required abdominal surgery, and needed TPN. Patients were excluded if they had signs of liver disease at baseline. Informed consent was obtained, and once screening lab work completed patients were randomized into one of two prospective treatment groups. Historic controls were included from previous two years prior to enrollment with selection based on same eligibility criteria.

Screening labs including AST, ALT, GGT, platelet count, INR, and triglyceride level were performed prior to or at enrollment. Results were required prior to randomization. Only one patient was enrolled but found to have abnormal INR so was not randomized.

Participant milestones

Measure	Smoflipid 20% Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Overall Study STARTED	12	12	24
Overall Study COMPLETED	12	12	24
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants	48 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	4 days n=5 Participants	5 days n=7 Participants	2 days n=5 Participants	3.5 days n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants	45 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants	48 participants n=4 Participants

PRIMARY outcome

Timeframe: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.

Population: All participants who received study lipid or were included as historic controls.

Cholestasis was defined as a direct bilirubin > 2 mg/dL on two measurements 5 to 7 days apart.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Number of Participants With Cholestasis	1 Participants	3 Participants	7 Participants

SECONDARY outcome

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.

Population: All participants included.

Weight velocity was calculated as the difference in weight from end to start of study divided by number of days enrolled in study.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Weight Velocity	28.6 grams per day Standard Deviation 10.6	23.0 grams per day Standard Deviation 11.9	24.6 grams per day Standard Deviation 8.2

SECONDARY outcome

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.

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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Length Velocity	0.13 centimeters per day Standard Deviation 0.08	0.09 centimeters per day Standard Deviation 0.65	0.10 centimeters per day Standard Deviation 0.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Head Circumference (OFC) Velocity	0.09 centimeters per day Standard Deviation 0.03	0.07 centimeters per day Standard Deviation 0.06	0.10 centimeters per day Standard Deviation 0.05

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Average Total Calorie Intake	114.0 kcal per kilograms per day Standard Deviation 9.1	101.9 kcal per kilograms per day Standard Deviation 10.5	109.1 kcal per kilograms per day Standard Deviation 8.3

SECONDARY outcome

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.

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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Number of Patients With Enteral Autonomy at End of Study	9 Participants	10 Participants	23 Participants

SECONDARY outcome

Timeframe: Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.

Population: Only prospective participants were included in this analysis as retrospective controls did not have essential fatty acid levels obtained.

Essential fatty acid deficiency was defined as a triene to tetraene ratio greater than 0.05.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Number of Patients With Essential Fatty Acid Deficiency (EFAD)	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
AST Change Over Time	-8.3 units per liter Standard Deviation 25.5	2.9 units per liter Standard Deviation 62.4	5.1 units per liter Standard Deviation 49.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
ALT Change Over Time	8.7 units per liter Standard Deviation 14.9	25.3 units per liter Standard Deviation 53.3	17.2 units per liter Standard Deviation 51.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Alkaline Phosphatase Change Over Time	107.0 units per liter Standard Deviation 146.9	166.1 units per liter Standard Deviation 126.6	150.2 units per liter Standard Deviation 139.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Triglyceride Level Over Time	-18.5 mg/dL Standard Deviation 31.0	013.3 mg/dL Standard Deviation 54.5	13.7 mg/dL Standard Deviation 48.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Gamma Glutamyl Transferase (GGT) Over Time	-0.8 units per liter Standard Deviation 99.7	55.7 units per liter Standard Deviation 73.3	37.3 units per liter Standard Deviation 121.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Number of Patients With Retinopathy of Prematurity	2 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease	2 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Smoflipid 20% n=12 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=12 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic n=24 Participants A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
NICU Length of Stay	72.2 days Standard Deviation 57.6	33.3 days Standard Deviation 46.0	40.2 days Standard Deviation 42.2

SECONDARY outcome

Timeframe: ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.

Population: Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan.

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.

Outcome measures

Measure	Smoflipid 20% n=10 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=10 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Three Year Development- Communication	40.3 score on a scale Standard Deviation 22.4	41.2 score on a scale Standard Deviation 17.7	—

SECONDARY outcome

Timeframe: three year chronological age 3 years and 0 days to 3 years and 364 days

Population: Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan.

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.

Outcome measures

Measure	Smoflipid 20% n=10 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=10 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Three Year Development: Gross Motor	43.0 score on a scale Standard Deviation 24.2	54.1 score on a scale Standard Deviation 8.19	—

SECONDARY outcome

Timeframe: three year chronological age (3 years and 0 days to 3 years and 364 days)

Population: Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan.

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.

Outcome measures

Measure	Smoflipid 20% n=10 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=10 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Three Year Development: Fine Motor	32.2 score on a scale Standard Deviation 21.6	34.9 score on a scale Standard Deviation 19.1	—

SECONDARY outcome

Timeframe: three year chronological age (3 years and 0 days to 3 years and 364 days)

Population: Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan.

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

Outcome measures

Measure	Smoflipid 20% n=10 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=10 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Three Year Development: Problem Solving	47.9 score on a scale Standard Deviation 19.5	47.3 score on a scale Standard Deviation 11.1	—

SECONDARY outcome

Timeframe: three year chronological age (3 years and 0 days to 3 years and 364 days)

Population: Only the prospective patients treated by the research team were included in developmental assessment. The Intralipid 20% Historic group was not included in analysis as these patients were not treated by the research team and developmental screening could not be performed on these patients. Data for the "Intralipid 20% Historic" arm was not collected as specified by the study protocol and statistical analysis plan.

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.

Outcome measures

Measure	Smoflipid 20% n=10 Participants Smoflipid 20% is an intravenous lipid emulsions containing soy, MCT, olive, and fish oils. Patients randomized to this arm received the composite fish oil lipid, Smoflipid 20%, at dosing goal of 3 g/kg/day. Patients were started on a dose of 1 g/kg/day and titrated by 1g/kg/day up to goal. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations. Smoflipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Reduction n=10 Participants Intralipid 20% is an intravenous lipid emulsion containing soybean oil. Patients randomized to this arm received soy-based lipid (Intralipid 20%) at a goal dose of 1 g/kg/day. Lipid was increased incrementally by 0.5 g/kg/day every 3-5 days for growth less than goal of 25-30 g/kg/day despite maximization or remaining TPN components. Once adequate weight gain was established Intralipid was weaned back to goal of 1 g/kg/day by 0.5-1 g/kg/day increments. With enteral feeding advancement Intralipid was continued at 1 g/kg/day until TPN is stopped. Intralipid was infused over a 24 hour period, with infusion changed every 12 hours per hospital policy.	Intralipid 20% Historic A control group of historic patients who received Intralipid 20% at dosing of greater than or equal to 2 g/kg/day were included. Patients were enrolled using the same eligibility criteria as prospective patients. Given patients were retrospective, only available data in the patient electronic medical record was recorded.
Three Year Development: Personal Social	46.5 score on a scale Standard Deviation 20.6	47.1 score on a scale Standard Deviation 10.5	—

Adverse Events

Smoflipid 20%

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Intralipid 20% Reduction

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Smoflipid 20% n=12 participants at risk Patients randomized to this arm received the composite fish oil lipid, Smoflipid, at standard dosing up to 3 g/kg/day. Patients started on a dose of 1 g/kg/day and titrated up to maximum dose. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations.	Intralipid 20% Reduction n=12 participants at risk Patients randomized to this arm received soy-based lipid (Intralipid) at a dose of 1 g/kg/day throughout their enrollment in the study.
Product Issues Rapid infusion	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Gastrointestinal disorders Intestinal perforation	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Gastrointestinal disorders gastrointestinal bleed	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).

Other adverse events

Measure	Smoflipid 20% n=12 participants at risk Patients randomized to this arm received the composite fish oil lipid, Smoflipid, at standard dosing up to 3 g/kg/day. Patients started on a dose of 1 g/kg/day and titrated up to maximum dose. As enteral nutrition was advanced the lipid dose was weaned per study protocol and dietary recommendations.	Intralipid 20% Reduction n=12 participants at risk Patients randomized to this arm received soy-based lipid (Intralipid) at a dose of 1 g/kg/day throughout their enrollment in the study.
Gastrointestinal disorders Elevated GGT	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	16.7% 2/12 • Number of events 2 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Gastrointestinal disorders Elevated LFT	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	16.7% 2/12 • Number of events 2 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Blood and lymphatic system disorders Anemia	66.7% 8/12 • Number of events 15 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	50.0% 6/12 • Number of events 12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 2/12 • Number of events 2 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	16.7% 2/12 • Number of events 3 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	16.7% 2/12 • Number of events 2 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hypophosphatemia	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	16.7% 2/12 • Number of events 2 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hypoglycemia	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	16.7% 2/12 • Number of events 2 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hypertriglyceridemia	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	16.7% 2/12 • Number of events 2 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hypochloremia	16.7% 2/12 • Number of events 3 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Metabolic alkalosis	16.7% 2/12 • Number of events 2 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Blood and lymphatic system disorders Neutropenia	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hyponatremia	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Blood and lymphatic system disorders Thrombosis	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Infections and infestations Urinary tract infection	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hypernatremia	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Hyperchloremia	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Essential fatty acid deficiency	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Elevated magnesium	0.00% 0/12 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Respiratory, thoracic and mediastinal disorders Increased respiratory support	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Metabolism and nutrition disorders Elevated alkaline phosphatase	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).
Gastrointestinal disorders Feeding intolerance	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).	8.3% 1/12 • Number of events 1 • Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks. Adverse event data was not collected during the retrospective analysis of the historical control arm (Intralipid 20% Historic).

Additional Information

Dr. Katie Huff

Indiana University School of Medicine

Phone: 3179449395

Email: huffka@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place