A Phase 1/2 interventional study of SMOFlipid in Cholestasis and Jaundice, Obstructive, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 23 Weeks to 1 Year, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-17.
Sponsored by University of Florida · Phase 1/2, Interventional, and Supportive care
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.
150 studies on the registry are indexed under Cholestasis; 18 are open to participants now.
This study's enrollment of 2 is below the median of 53 across 90 interventional studies indexed under Cholestasis.
Browse Cholestasis studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Parenteral nutrition (PN)
Inflammation of the Liver Between the Groups
Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.
Time frame: 6 months
Measurement of Head Circumference for Growth Increase
Growth increase will be measured by head circumference of participants.
Time frame: 6 months
Measurement of Weight for Growth Increase
Growth increase will be measured by weight of participants.
Time frame: 6 months
Measurement of Length for Growth Increase
Growth increase will be measured by length of participants.
Time frame: 6 months
Number of Subjects Requiring Surgery
Time frame: 6 months
Number of Concomitant Medications Received
Time frame: 6 months
Length of IV Nutritional Therapy
Time frame: 6 months
Number of Subjects Receiving Formula Diet
Enteral administration of formula will be noted
Time frame: 6 months
Number of Subjects Receiving Breast Milk Diet
Enteral administration of breast milk will be noted
Time frame: 6 months
Number of Participants With Adverse Events Related to Treatment
Laboratory values will be used to determine adverse events.
Time frame: 6 months
Carbon Dioxide Total
Laboratory value that determines acid-base balance
Time frame: 6 months
Total Protein
Laboratory value that evaluates liver function
Time frame: 6 months
Albumin
Laboratory value that evaluates liver function
Time frame: 6 months
Aspartate Aminotransferase
Laboratory value that evaluates liver function
Time frame: 6 months
Alanine Aminotransferase
Laboratory value that evaluates liver function
Time frame: 6 months
Total Bilirubin
Laboratory value that evaluates liver function
Time frame: 6 months
Serum Glucose
Laboratory values that evaluates glucose in the blood
Time frame: 6 months
Alkaline Phosphatase
Laboratory value that evaluates liver function
Time frame: 6 months
Triglyceride
Laboratory value that evaluates liver function and metabolism of fat
Time frame: 6 months
Number of Days on Mechanical Ventilation Via Endotracheal Tube
Length of therapy with mechanical ventilation
Time frame: 6 months
Number of Days on Oxygen Via Continuous Positive Airway Pressure
Length of therapy with nasal continuous positive airway pressure
Time frame: 6 months
Number of Days on Oxygen Via Nasal Cannula
Length of therapy with nasal cannula
Time frame: 6 months
Number of Days With Central Venous Catheter
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
| Milestone | SMOFlipid |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.
No measurements were reported for this outcome.
Growth increase will be measured by head circumference of participants.
No measurements were reported for this outcome.
Growth increase will be measured by weight of participants.
No measurements were reported for this outcome.
Growth increase will be measured by length of participants.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Enteral administration of formula will be noted
No measurements were reported for this outcome.
Enteral administration of breast milk will be noted
No measurements were reported for this outcome.
Laboratory values will be used to determine adverse events.
No measurements were reported for this outcome.
Laboratory value that determines acid-base balance
No measurements were reported for this outcome.
Laboratory value that evaluates liver function
No measurements were reported for this outcome.
Laboratory value that evaluates liver function
No measurements were reported for this outcome.
Laboratory value that evaluates liver function
No measurements were reported for this outcome.
Laboratory value that evaluates liver function
No measurements were reported for this outcome.
Laboratory value that evaluates liver function
No measurements were reported for this outcome.
Laboratory values that evaluates glucose in the blood
No measurements were reported for this outcome.
Laboratory value that evaluates liver function
No measurements were reported for this outcome.
Laboratory value that evaluates liver function and metabolism of fat
No measurements were reported for this outcome.
Length of therapy with mechanical ventilation
No measurements were reported for this outcome.
Length of therapy with nasal continuous positive airway pressure
No measurements were reported for this outcome.
Length of therapy with nasal cannula
No measurements were reported for this outcome.
No measurements were reported for this outcome.
A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood.
No measurements were reported for this outcome.
A review of the subject's medical record will determine the location from which positive blood cultures were obtained.
No measurements were reported for this outcome.
A review of the subject's medical record will determine the location from which positive blood cultures were obtained.
No measurements were reported for this outcome.
Collected over <1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SMOFlipid | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | SMOFlipid |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | SMOFlipid |
|---|---|
| Female | 1 |
| Male | 1 |
| Region of Enrollment(participants) | SMOFlipid |
|---|---|
| United States | 2 |
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2016 to primary completion in Dec 2016, 7 months.
Results were first posted in Apr 2017, 4 months after primary completion.
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This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SMOFlipid