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

• Conditions: Total Parenteral Nutrition-induced Cholestasis

• Registration Number: NCT02534077
• Lead Sponsor: Pediatrix

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

Study Timeline

• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Status Verified: 2019-04
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Hospital of San Antonio; 🇺🇸 San Antonio, Texas, United States