Phase 3 Study to Compare Safety and Efficacy of Smoflipid... | NCT02579265

NCT02579265

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Smoflipid 20%	Experimental	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".	Drug: Smoflipid 20% (investigational lipid for parenteral nutrition)
Intralipid® 20%	Active Comparator	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".	Drug: Intralipid® 20%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smoflipid 20% (investigational lipid for parenteral nutrition)	Drug	Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample	Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.	Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl

Secondary Outcomes

Measure	Description	Time Frame
Body Weight (Change From Baseline)	Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).	Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Steven A Abrams, MD	University of Texas at Austin	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Lucile Packard Children's Hospital		Palo Alto	California	94304	United States
UC San Diego Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39374788	Derived	Abrams SA, Ernst KD, Weitkamp JH, Mascarenhas M, Anderson-Berry A, Rudolph J, Ling CY, Robinson DT, Shores D, Hair AB, Lai J, Lane B, McCallie KR, Levit O, Kim JH. Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring Prolonged Parenteral Nutrition - A Randomized, Double-Blind, Multicenter, Controlled Trial. J Nutr. 2024 Dec;154(12):3615-3625. doi: 10.1016/j.tjnut.2024.10.005. Epub 2024 Oct 5.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 5, 2020	Jul 30, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
BG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

days

Title

Denominators

Categories

Combined

- ParticipantsOG00078
- ParticipantsOG00183

Title	Measurements
	OG0003

Secondary

Body Weight (Change From Baseline)

Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).

The numbers at different timepoints refer to 100%. Timepoints >10% of Subjects (overall) are displayed.

Posted

Count of Participants

Participants

Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up)

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Body Length (Change From Baseline)

Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).

The numbers at different timepoints refer to 100%. Timepoints >10% of Subjects (overall) are displayed.

Posted

Count of Participants

Participants

Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Head Circumference (Change From Baseline)

Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).

The numbers at different timepoints refer to 100%. Timepoints >10% of Subjects (overall) are displayed.

Posted

Count of Participants

Participants

Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Time to Full Enteral or Oral Feeds

Time to full enteral or oral feeds (i.e. PN weaning) is the time from the randomization date to the date of the first full enteral or oral Feeds.

The Standard Deviation for Time to Event was not calculated. NA=Not available

Posted

Median

95% Confidence Interval

Time to event in days

Day 29/end of treatment, if continued: Day 85/end of treatment

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)

RBC refers to red blood cells. Timepoints >10% of Subjects (overall) are displayed.

Over time analysis of laboratory parameters were assessed at all timepoints as available

Posted

Mean

Standard Deviation

ug/mL

Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Length of Stay in Hospital

Length of stay in hospital (time from randomization to discharge) was be calculated.

NA=Not available

Posted

Median

95% Confidence Interval

Median time (days) until discharge

Day 1- Follow up (7 days after end of treatment)

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Ratio of Independent Bloodstream Infections to Number of Days on Study Medication

The Ratio is the incidence of bloodstream infection by numbers of day on study medication.

Posted

Mean

Standard Deviation

ratio

Day 1-29 or -85 if continued + Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication

Posted

Count of Participants

Participants

Day 1-29 or -85 if continued + Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Number of Patients Who Complete PN Treatment Without Lipid Minimization

The Analysis was conducted over all study phases.

Posted

Count of Participants

Participants

Day 1-29 or -85 if continued + Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels

Posted

Count of Participants

Participants

Day 1-29 or -85 if continued + Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study

The area under the curve (AUC>1.5) is defined as the area between conjugated bilirubin concentrations > 1.5 mg/dL and the horizontal line at 1.5 mg/dL, restricted by the time point of study withdrawal, if applicable. Analysis displays the summary of Area Under the Curve of Bilirubin Levels for the Time Period in Which Conjugated are >1.5 mg/dL

Missing

Posted

Mean

Standard Deviation

mg/dl*days

Day 1-29 or -85 if continued + Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization

The Analysis was performed over the entire study period.

Missing

Posted

Mean

Standard Deviation

Cumulative days

Day 1-29 or -85 if continued + Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First)

NA=Not available Since the number of events was not sufficient, no further analysis was performed.

Posted

Mean

95% Confidence Interval

Number of days

Day 1-29 or -85 if continued + Follow-up

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)

Over time analysis of laboratory parameters were assessed at all timepoints as available. Timepoints >10% of Subjects (overall) are displayed.

Posted

Mean

Standard Deviation

ug/mL

Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Secondary

Holman Index

Essential fatty acid deficiency is based on the ratio of Mead acid and Arachidonic acid (also called the triene/tetraene ratio or Holman index; Holman, 1960). A ratio of > 0.2 was considered abnormal (=essential fatty acid deficiency; Holman et al., 1979). Timepoints with >10% of patients are displayed.

Posted

Count of Participants

Participants

Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment

ID	Title	Description
OG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
OG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intralipid® 20%	Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.	1	78	5	78	55	78
EG001	Smoflipid 20%	Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions". Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.	1	83	8	83	59	83

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiogenic shock	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected83 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected83 at risk
Necrotising colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0011 events1 affected83 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected83 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected83 at risk
Escherichia sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected83 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected83 at risk
Meningitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected83 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected83 at risk
Sepsis neonatal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected83 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected83 at risk
Tracheal injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected83 at risk
Candida test positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected83 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected83 at risk
Pulmonary vein stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected83 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected83 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00011 events8 affected78 at risk EG0015 events4 affected83 at risk
Anemia neonatal	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00020 events17 affected78 at risk EG00116 events15 affected83 at risk
Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0006 events4 affected78 at risk EG0013 events3 affected83 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected78 at risk EG0018 events7 affected83 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected78 at risk EG0014 events4 affected83 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected78 at risk EG0019 events7 affected83 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 events4 affected78 at risk EG0014 events3 affected83 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected78 at risk EG0015 events5 affected83 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00025 events16 affected78 at risk EG00127 events15 affected83 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0009 events9 affected78 at risk EG0017 events7 affected83 at risk
Bilirubin conjugated increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0008 events7 affected78 at risk EG0013 events3 affected83 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected78 at risk EG0011 events1 affected83 at risk
C-reactive protein increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected78 at risk EG0018 events6 affected83 at risk
Cardiac murmur	Investigations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected78 at risk EG0011 events1 affected83 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00012 events11 affected78 at risk EG00110 events10 affected83 at risk
Hematocrit decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected78 at risk EG0012 events2 affected83 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected78 at risk EG0017 events5 affected83 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected78 at risk EG0017 events5 affected83 at risk
Tachypnea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected78 at risk EG0017 events6 affected83 at risk

ID	Term
D006963	Hyperphagia

ID	Term
C000709826	SMOFlipid
D010288	Parenteral Nutrition
C545823	soybean oil, phospholipid emulsion
D005217	Fat Emulsions, Intravenous

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy
D004655	Emulsions
D003102	Colloids
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D057947	Parenteral Nutrition Solutions
D019999	Pharmaceutical Solutions
D012996	Solutions
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D020313	Specialty Uses of Chemicals

ParticipantsBG002161

ParticipantsBG002150

ParticipantsBG002151

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms