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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.
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:
Subjects will remain on SMOFlipid until weaned from PN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMOFlipid | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMOFlipid | Drug | 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 | Description | Time Frame |
|---|---|---|
| Inflammation of the Liver Between the Groups | Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Head Circumference for Growth Increase | Growth increase will be measured by head circumference of participants. | 6 months |
| Measurement of Weight for Growth Increase | Growth increase will be measured by weight of participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days on Mechanical Ventilation Via Endotracheal Tube | Length of therapy with mechanical ventilation | 6 months |
| Number of Days on Oxygen Via Continuous Positive Airway Pressure | Length of therapy with nasal continuous positive airway pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josef Neu, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inflammation of the Liver Between the Groups | Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups. | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
<1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josef Neu, MD | University of Florida | 352-273-8985 | neuj@peds.ufl.edu |
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| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D041781 | Jaundice, Obstructive |
| D006963 | Hyperphagia |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D007565 | Jaundice |
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| ID | Term |
|---|---|
| C000709826 | SMOFlipid |
| D010288 | Parenteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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|
|
| 6 months |
| Measurement of Length for Growth Increase | Growth increase will be measured by length of participants. | 6 months |
| Number of Subjects Requiring Surgery | 6 months |
| Number of Concomitant Medications Received | 6 months |
| Length of IV Nutritional Therapy | 6 months |
| Number of Subjects Receiving Formula Diet | Enteral administration of formula will be noted | 6 months |
| Number of Subjects Receiving Breast Milk Diet | Enteral administration of breast milk will be noted | 6 months |
| Number of Participants With Adverse Events Related to Treatment | Laboratory values will be used to determine adverse events. | 6 months |
| Carbon Dioxide Total | Laboratory value that determines acid-base balance | 6 months |
| Total Protein | Laboratory value that evaluates liver function | 6 months |
| Albumin | Laboratory value that evaluates liver function | 6 months |
| Aspartate Aminotransferase | Laboratory value that evaluates liver function | 6 months |
| Alanine Aminotransferase | Laboratory value that evaluates liver function | 6 months |
| Total Bilirubin | Laboratory value that evaluates liver function | 6 months |
| Serum Glucose | Laboratory values that evaluates glucose in the blood | 6 months |
| Alkaline Phosphatase | Laboratory value that evaluates liver function | 6 months |
| Triglyceride | Laboratory value that evaluates liver function and metabolism of fat | 6 months |
| 6 months |
| Number of Days on Oxygen Via Nasal Cannula | Length of therapy with nasal cannula | 6 months |
| Number of Days With Central Venous Catheter | 6 months |
| Number of Blood Infections | 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 months |
| Numbers of Blood Infection Obtained From a Venipuncture | A review of the subject's medical record will determine the location from which positive blood cultures were obtained. | 6 months |
| Numbers of Blood Infection Obtained From a Central Venous Catheter | A review of the subject's medical record will determine the location from which positive blood cultures were obtained. | 6 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Measurement of Head Circumference for Growth Increase | Growth increase will be measured by head circumference of participants. | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Measurement of Weight for Growth Increase | Growth increase will be measured by weight of participants. | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Measurement of Length for Growth Increase | Growth increase will be measured by length of participants. | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Number of Subjects Requiring Surgery | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Number of Concomitant Medications Received | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Length of IV Nutritional Therapy | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Number of Subjects Receiving Formula Diet | Enteral administration of formula will be noted | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Number of Subjects Receiving Breast Milk Diet | Enteral administration of breast milk will be noted | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Number of Participants With Adverse Events Related to Treatment | Laboratory values will be used to determine adverse events. | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Carbon Dioxide Total | Laboratory value that determines acid-base balance | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Total Protein | Laboratory value that evaluates liver function | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Albumin | Laboratory value that evaluates liver function | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Aspartate Aminotransferase | Laboratory value that evaluates liver function | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Alanine Aminotransferase | Laboratory value that evaluates liver function | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Total Bilirubin | Laboratory value that evaluates liver function | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Serum Glucose | Laboratory values that evaluates glucose in the blood | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Alkaline Phosphatase | Laboratory value that evaluates liver function | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Secondary | Triglyceride | Laboratory value that evaluates liver function and metabolism of fat | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Other Pre-specified | Number of Days on Mechanical Ventilation Via Endotracheal Tube | Length of therapy with mechanical ventilation | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Other Pre-specified | Number of Days on Oxygen Via Continuous Positive Airway Pressure | Length of therapy with nasal continuous positive airway pressure | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Other Pre-specified | Number of Days on Oxygen Via Nasal Cannula | Length of therapy with nasal cannula | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Other Pre-specified | Number of Days With Central Venous Catheter | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Other Pre-specified | Number of Blood Infections | A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood. | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Other Pre-specified | Numbers of Blood Infection Obtained From a Venipuncture | A review of the subject's medical record will determine the location from which positive blood cultures were obtained. | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
|
| Other Pre-specified | Numbers of Blood Infection Obtained From a Central Venous Catheter | A review of the subject's medical record will determine the location from which positive blood cultures were obtained. | Study was terminated due to insufficient enrollment | Posted | 6 months |
|
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D006932 |
| Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |