UnknownPhase 2

Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?

Canada24 participantsStarted 2009-01

Plain-language summary

The aim of this study is to determine the feasibility of conducting a trial to examine the efficacy of an ω3FA (Omega-3 fatty acid) containing balanced lipid emulsion in the prevention of progression of PNALD in infants with Intestinal Failure/Short Bowel Syndrome (SBS) and early liver dysfunction.

Who can participate

Age range24 Months

SexALL

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Inclusion criteria

✓. ≤ 24 months of age at enrollment
✓. Evidence of early hepatic dysfunction
✓. ≥ 40% of total calories administered by PN
✓. Meet one of the following diagnostic categories
✓. Expectation of the treating physician that the patient will require PN for at least 3 weeks following enrollment.
✓. Parents willing to participate including randomization

Exclusion criteria

✕. Sepsis or Hemodynamic Instability of any cause.
✕. Coagulopathy (Platelets ≤ 150 000, or INR ≥ 1.4)
✕. Hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients
✕. Current enrollment in another clinical trial involving a surgical or pharmacologic intervention
✕. Serum conjugated bilirubin \> 50 umol/L
✕. Hyperlipidaemia (any of)
✕. Treatment with intravenous N-Acetylcysteine or Ursodeoxycholic acid
✕. Renal insufficiency

What they're measuring

Mean serum conjugated bilirubin (umol/L)

Timeframe: 12 weeks

Trial details

NCT IDNCT00793195

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-09

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