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

Pediatrix

Status and phase: Phase 3

Conditions: Total Parenteral Nutrition-induced Cholestasis

Treatments: Drug: Omegaven

Study type: Expanded Access

Funder types: Other

Identifiers

NCT02534077

WIRB Study# 1155515

Details and patient eligibility

About

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.

Full description

Compassionate Use

Enrollment: 2 patients

Sex: All

Ages: 14 days to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)