SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SMOFlipid to Lessen the Severity of Neonatal Cholestasis

NCT02721277

Cholestasis Jaundice, Obstructive

TERMINATED PHASE1/PHASE2

Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

NCT02534077

Total Parenteral Nutrition-induced Cholestasis

APPROVED_FOR_MARKETING

Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury

NCT01425567

Liver Disease

APPROVED_FOR_MARKETING

Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

NCT02357576

Cholestasis

COMPLETED PHASE3

Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury

NCT01089426

Liver Injury

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cholestasis Growth Failure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SMOFlipid

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SMOF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

14 Days

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No