Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

NCT02534077 | Unknown

• 1 other identifier: WIRB Study# 1155515
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Conditions

Total Parenteral Nutrition-induced Cholestasis

Keywords

omegaven; cholestasis; parenteral nutrition associated liver disease

Interventions

Omegaven DIETARY_SUPPLEMENT

Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Also known as: omega-3 enriched fat emulsion

Eligibility Criteria

• Age: 14 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL. The qualifying measurements of 2 mg/dL or 4 mg/dL direct bilirubin must be consecutive and obtained at least 24 hours apart.
• Be expected to require intravenous nutrition for at least an additional 28 days
• Patient must have documented failure of or ineligibility for the following therapies to prevent progression of PNALD:
• Reduction of Intralipid® to 1 g/kg/day
• Limiting trace minerals including copper and manganese
• Initiation and use of Ursodiol
• Cycling of parenteral nutrition
• Advancement of enteral feedings
• Parental informed consent must be signed.

You may not qualify if:

• Have a congenitally lethal condition (e.g. Trisomy 13).
• Have clinically severe bleeding not able to be managed with routine measures.
• Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
• Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
• Has culture positive sepsis

Sponsors & Collaborators

• Pediatrix: lead

Study Sites (1)

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Cholestasis

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Kaashif Ahmad, MD

  Pediatrix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 27, 2015
• Last Updated: July 26, 2024

Record last verified: 2019-04

Locations

US (1)