SMOFlipid to Lessen the Severity of Neonatal Cholestasis

• Sponsor: University of Florida (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02721277
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function. In early PN-associated cholestasis, the dose of traditional soy based lipid is limited to 1 g/kg/day which often limits the growth capacity of parenteral nutrition-dependent infants. Inadequate growth is directly related to poor neurological outcomes, failure to facilitate mechanical ventilation, and less growth of the neonate's already damaged intestine. Ultimately, these outcomes can lead to severe disability and death. To mitigate these deleterious effects and optimize growth, parenteral nutrition-dependent infants with cholestasis who are not adequately growing on 1 g/kg/day of soy-based lipid emulsion must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth.

SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids. The utility of Omegaven and soy-based lipid emulsion is limited as these are restricted to 1 g/kg/day in cholestatic infants. SMOFlipid is safe to be provided at the usual goal infusion amount of 3 g/kg/day. Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid requirements. Its use in situations in which growth is inadequate in babies who must be restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase their chances of both a good neurological outcome and survival.

The aim of this research study is to determine if the unique formulation of SMOFLipid will cause less hepatic inflammation compared to soy only intralipids.

Condition or Disease	Intervention/Treatment	Phase
Cholestasis; Jaundice, Obstructive	Drug: SMOFlipid	Phase 1/Phase 2

Detailed Description

The neonates who are being treated at the University of Florida Health Neonates Intensive Care Unit and are anticipated to need more than 21 days of intravenous nutrition will be considered as potential subjects. These subjects will receive the unique formulation of SMOFLipid

The following data will be collected from the subject's EMR by members of the research team:

• Lab values that evaluate liver function

• Growth parameters like head circumference, length, weight

• Medical/surgical history

• Time to resolution of bilirubin, time to liver transplant, time to death

• Length of hospital stay

• Rates of blood infections

Subjects will remain on SMOFlipid until weaned from PN.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil for Neonates With Parenteral Nutrition Induced Liver Injury
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Feb 2, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: SMOFlipid Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.

Drug: SMOFlipid; SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.; Other Names: Parenteral nutrition (PN)

Outcome Measures

Primary Outcome Measures

1. Inflammation of the Liver Between the Groups [6 months]

   Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.

Secondary Outcome Measures

1. Measurement of Head Circumference for Growth Increase [6 months]

   Growth increase will be measured by head circumference of participants.

2. Measurement of Weight for Growth Increase [6 months]

   Growth increase will be measured by weight of participants.

3. Measurement of Length for Growth Increase [6 months]

   Growth increase will be measured by length of participants.

4. Number of Subjects Requiring Surgery [6 months]

5. Number of Concomitant Medications Received [6 months]

6. Length of IV Nutritional Therapy [6 months]

7. Number of Subjects Receiving Formula Diet [6 months]

   Enteral administration of formula will be noted

8. Number of Subjects Receiving Breast Milk Diet [6 months]

   Enteral administration of breast milk will be noted

9. Number of Participants With Adverse Events Related to Treatment [6 months]

   Laboratory values will be used to determine adverse events.

10. Carbon Dioxide Total [6 months]

    Laboratory value that determines acid-base balance

11. Total Protein [6 months]

    Laboratory value that evaluates liver function

12. Albumin [6 months]

    Laboratory value that evaluates liver function

13. Aspartate Aminotransferase [6 months]

    Laboratory value that evaluates liver function

14. Alanine Aminotransferase [6 months]

    Laboratory value that evaluates liver function

15. Total Bilirubin [6 months]

    Laboratory value that evaluates liver function

16. Serum Glucose [6 months]

    Laboratory values that evaluates glucose in the blood

17. Alkaline Phosphatase [6 months]

    Laboratory value that evaluates liver function

18. Triglyceride [6 months]

    Laboratory value that evaluates liver function and metabolism of fat

Other Outcome Measures

1. Number of Days on Mechanical Ventilation Via Endotracheal Tube [6 months]

   Length of therapy with mechanical ventilation

2. Number of Days on Oxygen Via Continuous Positive Airway Pressure [6 months]

   Length of therapy with nasal continuous positive airway pressure

3. Number of Days on Oxygen Via Nasal Cannula [6 months]

   Length of therapy with nasal cannula

4. Number of Days With Central Venous Catheter [6 months]

5. Number of Blood Infections [6 months]

   A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood.

6. Numbers of Blood Infection Obtained From a Venipuncture [6 months]

   A review of the subject's medical record will determine the location from which positive blood cultures were obtained.

7. Numbers of Blood Infection Obtained From a Central Venous Catheter [6 months]

   A review of the subject's medical record will determine the location from which positive blood cultures were obtained.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Weeks to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Greater than 14 days old and less than 1 year of age.

• Greater than 1 kg.

• Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL

• Currently standard therapy with soy-based Intralipid

• Evidence of growth of weight, head circumference or length below our standards for post-menstrual age for at least 1 week.

• Be expected to require intravenous nutrition for at least an additional 21 days

Exclusion Criteria:

• Have a congenitally lethal condition.

• Have clinically severe bleeding or clinical liver failure not able to be managed with routine measures.

• Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.

• Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Josef Neu, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02721277
• Other Study ID Numbers: IRB201600068
• First Posted: Mar 29, 2016
• Last Update Posted: Apr 17, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Florida: Parenteral nutrition, Total; Infant, newborn; Cholestasis; Enterocolitis, Necrotizing
• Additional relevant MeSH terms: Cholestasis; Jaundice; Jaundice, Obstructive; SMOFlipid

Study Results

Participant Flow

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Overall Participants	2
Age (Count of Participants)
<=18 years	2 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Inflammation of the Liver Between the Groups
Description	Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

2. Secondary Outcome

Title	Measurement of Head Circumference for Growth Increase
Description	Growth increase will be measured by head circumference of participants.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

3. Secondary Outcome

Title	Measurement of Weight for Growth Increase
Description	Growth increase will be measured by weight of participants.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

4. Secondary Outcome

Title	Measurement of Length for Growth Increase
Description	Growth increase will be measured by length of participants.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

5. Secondary Outcome

Title	Number of Subjects Requiring Surgery
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

6. Secondary Outcome

Title	Number of Concomitant Medications Received
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

7. Secondary Outcome

Title	Length of IV Nutritional Therapy
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

8. Secondary Outcome

Title	Number of Subjects Receiving Formula Diet
Description	Enteral administration of formula will be noted
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

9. Secondary Outcome

Title	Number of Subjects Receiving Breast Milk Diet
Description	Enteral administration of breast milk will be noted
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

10. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Treatment
Description	Laboratory values will be used to determine adverse events.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

11. Secondary Outcome

Title	Carbon Dioxide Total
Description	Laboratory value that determines acid-base balance
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

12. Secondary Outcome

Title	Total Protein
Description	Laboratory value that evaluates liver function
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

13. Secondary Outcome

Title	Albumin
Description	Laboratory value that evaluates liver function
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

14. Secondary Outcome

Title	Aspartate Aminotransferase
Description	Laboratory value that evaluates liver function
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

15. Secondary Outcome

Title	Alanine Aminotransferase
Description	Laboratory value that evaluates liver function
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

16. Secondary Outcome

Title	Total Bilirubin
Description	Laboratory value that evaluates liver function
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

17. Secondary Outcome

Title	Serum Glucose
Description	Laboratory values that evaluates glucose in the blood
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

18. Secondary Outcome

Title	Alkaline Phosphatase
Description	Laboratory value that evaluates liver function
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

19. Secondary Outcome

Title	Triglyceride
Description	Laboratory value that evaluates liver function and metabolism of fat
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

20. Other Pre-specified Outcome

Title	Number of Days on Mechanical Ventilation Via Endotracheal Tube
Description	Length of therapy with mechanical ventilation
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

21. Other Pre-specified Outcome

Title	Number of Days on Oxygen Via Continuous Positive Airway Pressure
Description	Length of therapy with nasal continuous positive airway pressure
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

22. Other Pre-specified Outcome

Title	Number of Days on Oxygen Via Nasal Cannula
Description	Length of therapy with nasal cannula
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

23. Other Pre-specified Outcome

Title	Number of Days With Central Venous Catheter
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

24. Other Pre-specified Outcome

Title	Number of Blood Infections
Description	A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

25. Other Pre-specified Outcome

Title	Numbers of Blood Infection Obtained From a Venipuncture
Description	A review of the subject's medical record will determine the location from which positive blood cultures were obtained.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

26. Other Pre-specified Outcome

Title	Numbers of Blood Infection Obtained From a Central Venous Catheter
Description	A review of the subject's medical record will determine the location from which positive blood cultures were obtained.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to insufficient enrollment

Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Measure Participants	0

Adverse Events

Time Frame	<1 year
Arm/Group Title	SMOFlipid
Arm/Group Description	Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
All Cause Mortality
	SMOFlipid
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	SMOFlipid
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	SMOFlipid
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.