Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?
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ClinicalTrials.gov Identifier: NCT00793195 |
Recruitment Status : Unknown
Verified November 2011 by The Hospital for Sick Children.
Recruitment status was: Active, not recruiting
First Posted : November 19, 2008
Last Update Posted : November 3, 2011
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Condition or disease | Intervention/treatment | Phase |
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Short Bowel Syndrome Intestinal Failure Gastrointestinal Motility Disorder Mucosal Enteropathy | Drug: Intralipid 20% Drug: SMOFlipid 20% | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants? A Pilot Double Blind Randomized Controlled Trial |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | September 2011 |
Estimated Study Completion Date : | January 2012 |

Arm | Intervention/treatment |
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Active Comparator: 1) Intralipid
Fat Emulsions for Intravenous Nutrition
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Drug: Intralipid 20%
Dosing will be formulated according to a Nomogram for Parenteral Nutrition (PN) composition, which takes into account the percentage of the subject's caloric intake consumed parenterally. PN solution will be infused continuously over 12-24 hours by infusion pump, and the duration each day will depend on the enteral tolerance of the child. PN shall not be discontinued, unless the patient is taking 95% of calories enterally with good growth as evidence by appropriate weight gain. Subjects will receive the trial lipid for a total duration of 12 weeks or if they develop a serum conjugated bilirubin (sustained for 7 days) of 100 umol/l (6mg/dl) or full enteral tolerance prior to this end-point. Once the trial lipid is discontinued, in the event that PN is continued, subjects will return to the standard lipid preparation. A final follow-up data-point will be collected 4 weeks after the trial lipid is stopped. |
Experimental: 2) SMOFlipid
Fat Emulsions for Intravenous Nutrition
|
Drug: SMOFlipid 20%
Dosing will be formulated according to a Nomogram for Parenteral Nutrition (PN) composition, which takes into account the percentage of the subject's caloric intake consumed parenterally. PN solution will be infused continuously over 12-24 hours by infusion pump, and the duration each day will depend on the enteral tolerance of the child. PN shall not be discontinued, unless the patient is taking 95% of calories enterally with good growth as evidence by appropriate weight gain. Subjects will receive the trial lipid for a total duration of 12 weeks or if they develop a serum conjugated bilirubin (sustained for 7 days) of 100 umol/l (6mg/dl) or full enteral tolerance prior to this end-point. Once the trial lipid is discontinued, in the event that PN is continued, subjects will return to the standard lipid preparation. A final follow-up data-point will be collected 4 weeks after the trial lipid is stopped. |
- Mean serum conjugated bilirubin (umol/L) [ Time Frame: 12 weeks ]
- Proportion with the development of cholestasis (sustained serum conjugated bilirubin >50 umol/L for greater than 2 weeks in absence of sepsis) [ Time Frame: 12 and 16 weeks ]
- Proportion with progression of liver disease (sustained serum conjugated bilirubin >100 umol/L in absence of sepsis) [ Time Frame: 12 and 16 weeks ]
- Degree of enteral tolerance (%) [ Time Frame: 12 and 16 weeks ]
- Growth parameters [ Time Frame: 12 and 16 weeks ]
- Biochemical outcomes shall assess mean levels of "hepatic markers" (AST, ALT, ALP, GGT), coagulation parameters (PT, PTT, INR, platelets), serum lipid levels (triglycerides and cholesterol), serum albumin, and Nephelometry (lipid clearance). [ Time Frame: 12 and 16 weeks ]
- Immunologic outcomes shall include assessment of RBC phospholipids composition, C-reactive Protein (CRP) and serum immunologic marker (IL-1b, IL-2R, IL-6, IL-8, IL-10, TNF-α) assessment [ Time Frame: 12 and 16 weeks ]
- Feasibility of trial (recruitment, protocol adherence, estimated effect size [ Time Frame: 4, 12 and 16 weeks ]

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Ages Eligible for Study: | up to 24 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≤ 24 months of age at enrollment
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Evidence of early hepatic dysfunction
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Serum conjugated bilirubin ≥ 17 umol/L on 2 consecutive readings 7 days apart
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No evidence of sepsis
- Normal Temperature (T between 35.5C and 38.0C)
- Normal leukocyte count
- Normal platelet count
- No systemic septic symptoms
- No prior administration of Omegaven
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- ≥ 40% of total calories administered by PN
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Meet one of the following diagnostic categories
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Short Bowel Syndrome
- Abdominal surgical procedure including gastroschisis closure by any means and percutaneous drainage procedures within the past 6 months and has been receiving PN since surgery
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Intestinal Failure
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One of the following diagnoses for which the child is dependent on PN
- Gastrointestinal Motility Disorder
- Mucosal Enteropathy
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- 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
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Hyperlipidaemia (any of)
- LDL ≥ 4 mmol/L
- HDL ≥ 2 mmol/L
- Total cholesterol ≥ 5 mmol/L
- Triglycerides ≥ 1.5 mmol/L
- Treatment with intravenous N-Acetylcysteine or Ursodeoxycholic acid
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Renal insufficiency
- Creatinine ≥ 80 umol/L
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Disorders of Fluid Balance (any of)
- Serum Sodium < 130 mmol/L
- Serum Sodium > 145 mmol/L
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Unstable conditions
- Acute pulmonary edema
- Decompensated cardiac insufficiency
- Severe post-traumatic conditions
- Uncompensated diabetes mellitus
- Acute myocardial infarction
- Stroke within 3 months
- Thromboembolic event within 3 months
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Metabolic acidosis
- Serum Bicarbonate < 17 mmol/L

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793195
Canada, Alberta | |
Alberta Children's Hospital | |
Calgary, Alberta, Canada | |
Foothills Medical Center | |
Calgary, Alberta, Canada | |
Stollery Children's Hospital | |
Edmonton, Alberta, Canada | |
Canada, Ontario | |
Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada |
Principal Investigator: | Paul Wales | The Hospital for Sick Children |
Responsible Party: | Dr. Paul Wales, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00793195 |
Other Study ID Numbers: |
1000012566 |
First Posted: | November 19, 2008 Key Record Dates |
Last Update Posted: | November 3, 2011 |
Last Verified: | November 2011 |
Neonates Short Bowel Syndrome Intestinal Failure Liver Failure |
Parenteral Nutrition Intralipid SMOF |
Liver Diseases Short Bowel Syndrome Pathologic Processes Digestive System Diseases Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases |
Postoperative Complications Soybean oil, phospholipid emulsion SMOFlipid Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |