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

• Status: Unknown status
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Fresenius Kabi
• Treatments: SMOFlipid; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

1. ≤ 24 months of age at enrollment

2. Evidence of early hepatic dysfunction

• Serum conjugated bilirubin ≥ 17 umol/L on 2 consecutive readings 7 days apart

• 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

3. ≥ 40% of total calories administered by PN

4. Meet one of the following diagnostic categories

• 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

• Intestinal Failure

• One of the following diagnoses for which the child is dependent on PN

• Gastrointestinal Motility Disorder

• Mucosal Enteropathy

5. Expectation of the treating physician that the patient will require PN for at least 3 weeks following enrollment.

6. Parents willing to participate including randomization

Exclusion Criteria:

1. Sepsis or Hemodynamic Instability of any cause.

2. Coagulopathy (Platelets ≤ 150 000, or INR ≥ 1.4)

3. Hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients

4. Current enrollment in another clinical trial involving a surgical or pharmacologic intervention

5. Serum conjugated bilirubin > 50 umol/L

6. Hyperlipidaemia (any of)

• LDL ≥ 4 mmol/L

• HDL ≥ 2 mmol/L

• Total cholesterol ≥ 5 mmol/L

• Triglycerides ≥ 1.5 mmol/L

7. Treatment with intravenous N-Acetylcysteine or Ursodeoxycholic acid

8. Renal insufficiency

• Creatinine ≥ 80 umol/L

9. Disorders of Fluid Balance (any of)

• Serum Sodium < 130 mmol/L

• Serum Sodium > 145 mmol/L

10. 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

• Metabolic acidosis

• Serum Bicarbonate < 17 mmol/L