CholestasisSMOFNCT02412566
SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury
A study testing SMOFlipid in people with Cholestasis and Growth Failure, run by Baylor College of Medicine at 1 site in United States.
Trial summary
While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Read more about this study
- Who is it for?
- Ages 14 days to 1 year
- Conditions the study is for
- Cholestasis, Growth Failure
- What is being tested?
- SMOFlipid
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 days to 1 year
- All sexes
- Child
Who may be able to join
- Greater than 14 days old and less than 1 year of age.
- Greater than 1.5 kg.
- Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL, or currently receiving Omegaven (fish oil lipid emulsion) with a conjugated bilirubin between 0.0-1.9 mg/dL.
- Currently receiving 1 g/kg/day of either Omegaven (H-23365) or soy-based Intralipid (standard therapy)
- 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.
Who cannot join
- Have a congenitally lethal condition (e.g. Trisomy 13).
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil for Children With Parenteral Nutrition Induced Liver Injury
While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the calories that are lost from this relative decreased dose of lipids can be provided by adjusting the dextrose content of the PN solution and providing a higher glucose infusion rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is inadequate. Inadequate growth is a direct cause of poor outcomes including poorer neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of their often already damaged intestine. These outcomes can lead to severe disability and death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth.
SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated fatty acids which are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides showing a faster metabolic clearance than long-chain triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in what is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being limited to 1 g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids. 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.
Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help promote good growth while reducing the severity (or seriousness) of liver disease or help put an end to liver disease in infants.
Read the detailed description
Therapy with SMOFlipid will be provided at a targeted dose of 3 gm/kg/day (by continuous infusion). SMOFlipid will be initiated and advanced according to the following guidelines: Day 1 - provide 1 g/kg; Day 2 - provide 2 g/kg; Day 3 - provide 3 g/kg. SMOFlipid will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. The same standards of care provided to all patients receiving parenteral nutrition (PN) solution will be followed.
Essential fatty acid levels will be measured at 4 and 12 weeks after the initiation of SMOFlipid. This time frame will be used to assess essential fatty acids of both inpatients and outpatients. These labs are clinically indicated; therefore, we will record the results of the total fatty acid lipid profile panel from the medical record into our case report forms.
Patients will remain on SMOFlipid until weaned from PN. In the event that a patient who has been listed for a liver or liver/intestinal transplant has an organ become available, the participation in this protocol will not preclude them from receiving the transplant. SMOFlipid will not be administered post transplant.
If the infant no longer is requiring any PN, then the SMOFlipid will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires PN, then the SMOFlipid will be continued up until the infant no longer requires PN. The reason for stopping SMOFlipid when the infant no longer requires PN is that this would be the only reason many infants would still need IV access and therefore the risk of maintaining IV access only for the medication is likely to exceed the benefit of SMOFlipid at that point.
Babies who receive SMOFlipid are not precluded from receiving Omegaven per that compassionate use protocol (H-23365) if they meet the inclusion criteria for that protocol.
- Conditions
- Cholestasis, Growth Failure
- Being tested
- SMOFlipid
- Keywords
- cholestasis, growth failure, intravenous fat emulsion, SMOF
- Medical subject headings
- Cholestasis, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFlipidDrug
Also called SMOF
Therapy with SMOFlipid will be provided at a targeted dose of 3 gm/kg/day (by continuous infusion). SMOFlipid will be initiated and advanced according to the following guidelines: Day 1 - provide 1 g/kg; Day 2 - provide 2 g/kg; Day 3 - provide 3 g/kg. SMOFlipid will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholestasisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muralidhar Premkumar, Baylor College of Medicine
- Investigators
- Muralidhar H. Premkumar, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412566
- Sponsor's protocol ID
- H-34444
- Acronym
- SMOF
- Status last verified
- Aug 2025
- First submitted
- 25 Mar 2015
- Last updated
- 19 Aug 2025
- Results posted
- No
Publications
Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):81S-94S. doi: 10.1177/0148607111424411.
PubMed 22237883Goulet O, Antebi H, Wolf C, Talbotec C, Alcindor LG, Corriol O, Lamor M, Colomb-Jung V. A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2010 Sep-Oct;34(5):485-95. doi: 10.1177/0148607110363614.
PubMed 20852176Tomsits E, Pataki M, Tolgyesi A, Fekete G, Rischak K, Szollar L. Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infants requiring parenteral nutrition. J Pediatr Gastroenterol Nutr. 2010 Oct;51(4):514-21. doi: 10.1097/MPG.0b013e3181de210c.
PubMed 20531018
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of an Intravenous Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil for Children With Parenteral Nutrition Induced Liver Injury
- ClinicalTrials.gov ID
- NCT02412566
- Acronym / sponsor ID
- SMOF / H-34444
- Conditions
- Cholestasis, Growth Failure
- Keywords
- cholestasis, growth failure, intravenous fat emulsion, SMOF
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the calories that are lost from this relative decreased dose of lipids can be provided by adjusting the dextrose content of the PN solution and providing a higher glucose infusion rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is inadequate. Inadequate growth is a direct cause of poor outcomes including poorer neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of their often already damaged intestine. These outcomes can lead to severe disability and death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth.
SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated fatty acids which are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides showing a faster metabolic clearance than long-chain triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in what is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being limited to 1 g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids. 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.
Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help promote good growth while reducing the severity (or seriousness) of liver disease or help put an end to liver disease in infants.
Detailed description
Therapy with SMOFlipid will be provided at a targeted dose of 3 gm/kg/day (by continuous infusion). SMOFlipid will be initiated and advanced according to the following guidelines: Day 1 - provide 1 g/kg; Day 2 - provide 2 g/kg; Day 3 - provide 3 g/kg. SMOFlipid will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. The same standards of care provided to all patients receiving parenteral nutrition (PN) solution will be followed.
Essential fatty acid levels will be measured at 4 and 12 weeks after the initiation of SMOFlipid. This time frame will be used to assess essential fatty acids of both inpatients and outpatients. These labs are clinically indicated; therefore, we will record the results of the total fatty acid lipid profile panel from the medical record into our case report forms.
Patients will remain on SMOFlipid until weaned from PN. In the event that a patient who has been listed for a liver or liver/intestinal transplant has an organ become available, the participation in this protocol will not preclude them from receiving the transplant. SMOFlipid will not be administered post transplant.
If the infant no longer is requiring any PN, then the SMOFlipid will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires PN, then the SMOFlipid will be continued up until the infant no longer requires PN. The reason for stopping SMOFlipid when the infant no longer requires PN is that this would be the only reason many infants would still need IV access and therefore the risk of maintaining IV access only for the medication is likely to exceed the benefit of SMOFlipid at that point.
Babies who receive SMOFlipid are not precluded from receiving Omegaven per that compassionate use protocol (H-23365) if they meet the inclusion criteria for that protocol.
Study design
Who may qualify
- Ages
- 14 days to 1 year
- Sex
- All
- Age groups
- Child
Key inclusion criteria (6 listed)
- Greater than 14 days old and less than 1 year of age.
- Greater than 1.5 kg.
- Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL, or currently receiving Omegaven (fish oil lipid emulsion) with a conjugated bilirubin between 0.0-1.9 mg/dL.
- Currently receiving 1 g/kg/day of either Omegaven (H-23365) or soy-based Intralipid (standard therapy)
- Evidence of growth of weight, head circumference or length below our standards for post-menstrual age for at least 1 week.
Key exclusion criteria (4 listed)
- Have a congenitally lethal condition (e.g. Trisomy 13).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMOFlipidAlso: SMOFTherapy with SMOFlipid will be provided at a targeted dose of 3 gm/kg/day (by continuous infusion). SMOFlipid will be initiated and advanced according to the following guidelines: Day 1 - provide 1 g/kg; Day 2 - provide 2 g/kg; Day 3 - provide 3 g/kg. SMOFlipid will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 22237883Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):81S-94S. doi: 10.1177/0148607111424411.
- Background: PubMed 20852176Goulet O, Antebi H, Wolf C, Talbotec C, Alcindor LG, Corriol O, Lamor M, Colomb-Jung V. A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2010 Sep-Oct;34(5):485-95. doi: 10.1177/0148607110363614.
- Background: PubMed 20531018Tomsits E, Pataki M, Tolgyesi A, Fekete G, Rischak K, Szollar L. Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infants requiring parenteral nutrition. J Pediatr Gastroenterol Nutr. 2010 Oct;51(4):514-21. doi: 10.1097/MPG.0b013e3181de210c.
- Children's Nutrition Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muralidhar H. Premkumar, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMOFlipid in people with Cholestasis and Growth Failure, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412566, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.