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

Total Parenteral Nutrition-induced Cholestasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534077
• Other study ID #: WIRB Study# 1155515
• Status: Completed
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholestasis
• Total Parenteral Nutrition-induced Cholestasis

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Culture positive bloodstream infection	Calculate the number (total and daily rate) of bloodstream infections prior to therapy, in each baby receiving Omegaven and compare with the previous rate.	Maximum 2 years
Primary	Death associated with liver disease	Those patients with death only associated with liver diseasepre-treatment period and the expected rate of growth.	Maximum 2 years
Secondary	Liver transplantation		Maximum 2 years
Secondary	Growth over time as determined by weight in grams.		Maximum 2 years
Secondary	Growth over time as measured by length in cm.		Maximum 2 years
Secondary	Growth over time as measured by head circumference in cm.		Maximum 2 years
Secondary	Development of essential fatty acid (EFA) deficiency as measured by triene:tetraene ratio in those with prolonged NPO status.		Maximum 2 years
Secondary	Hyperlipidemia as measured by triglyceride level		Maximum 2 years