Safety Study of SMOFlipid for Malnutrition in Children and Adults
This study is looking at the safety of SMOFlipid, a special liquid nutrition given through a vein (intravenous infusion), for children and adults who need long-term feeding this way. SMOFlipid is a mix of different oils. Researchers want to see if using SMOFlipid can help prevent two problems: Essential Fatty Acid Deficiency (EFAD), which is when your body doesn't get enough important fats, and Parenteral Nutrition Associated Cholestasis (PNAC), a liver problem. The study includes patients aged 1 month and older who are expected to receive this type of nutrition for at least 8 weeks. The study aims to enroll 100 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment (SMOFlipid). It aims to enroll 100 participants, including children and adults.
- What's involved
- Participants will receive SMOFlipid as part of their nutritional support for a minimum of 8 weeks and up to one year, as long as they need this type of nutrition.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored from the start of treatment until after the end of their last study nutrition treatment, which can last up to one year.
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Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
At a glance
Conditions
Where it's being run
5 sites across 5 statesStudy leadership
- Jeffrey Rudolph, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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What this trial measures
- Incidence of PNACStart of Treatment until After End of Last Study PN Duration of Treatment: Study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as PN is indicated, up to 1 year (365 consecutive days).
defined as direct bilirubin level \> 2 mg/dL, confirmed by a second sample collected 7 days after the first sample
- Time to direct bilirubin > 2mg/dLStart of Treatment until After End of Last Study PN Duration of Treatment: Study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as PN is indicated, up to 1 year (365 consecutive days).
(confirmed by a second sample collected 7 days after the first)
- Incidence of EFADStart of Treatment until After End of Last Study PN Duration of Treatment: Study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as PN is indicated, up to 1 year (365 consecutive days).
Triene/tetraene ratio in total plasma to assess EFAD (Holman 1960), Severity of EFAD will be graded based on triene/tetraene ratio, as suspected ≥ 0.05, moderate ≥ 0.20 and severe ≥ 0.40 (Cober et al 2012)
- Incidence of clinical EFADStart of Treatment until After End of Last Study PN Duration of Treatment: Study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as PN is indicated, up to 1 year (365 consecutive days).
- Fatty acidsStart of Treatment until After End of Last Study PN Duration of Treatment: Study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as PN is indicated, up to 1 year (365 consecutive days).
analyzed in total plasma, including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid