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

NCT ID: NCT02534077

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

Detailed Description

Compassionate Use

Conditions

Total Parenteral Nutrition-induced Cholestasis

Interventions

Omegaven

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.

Intervention Type: DIETARY_SUPPLEMENT

Omegaven

Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 2 years.

Intervention Type: DRUG

Omegaven

If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.

Intervention Type: DRUG

Other Intervention Names

omega-3 enriched fat emulsion

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Be expected to require intravenous nutrition for at least an additional 28 days

3. 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

4. Parental informed consent must be signed.

Exclusion Criteria

1. Have a congenitally lethal condition (e.g. Trisomy 13).

2. Have clinically severe bleeding not able to be managed with routine measures.

3. Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.

4. Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

5. Has culture positive sepsis

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatrix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaashif Ahmad, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrix

Locations

Children's Hospital of San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

WIRB Study# 1155515

Identifier Type: -

Identifier Source: org_study_id