Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage (NCT01861834) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage
United States
Plain-language summary
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.
Who can participate
Age range2 Months – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The targeted population for enrollment is the cohort of patients with TPN-dependent short bowel syndrome, defined as any pediatric patient who, following abdominal surgery, has a residual small bowel length less than 25% of that predicted for gestational age or requires postoperative TPN for more than 42 days because of gastrointestinal intolerance and who has developed TPN-associated liver disease sufficient to pose a significant risk for progression to liver failure based on the following criteria:
* Total serum bilirubin concentration greater than 3 mg/dL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.
PLUS EITHER:
• Platelet count less than 200,000/μL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.
OR
• Serum albumin concentration less than 3.2 mg/dL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.
Patients with coagulopathy due to parenteral nutrition-associated liver disease (INR \> 1.2) will be potential candidates for enrollment, because patients with an elevated INR exceeding 2 have demonstrated resolution of coagulopathy after treatment with Omegaven®. Similarly, patients with hyperlipidemia will be potential candidates for enrollment.
Alternatively, patients currently receiving Omegaven tha…