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

Primary Purpose

Total Parenteral Nutrition-induced Cholestasis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Omegaven

About this trial

This is an interventional treatment trial for Total Parenteral Nutrition-induced Cholestasis focused on measuring omegaven, cholestasis, parenteral nutrition associated liver disease

Eligibility Criteria

14 Days - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Children's Hospital of San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Drug: Omegaven

Outcomes

Primary Outcome Measures

Death associated with liver disease

Those patients with death only associated with liver diseasepre-treatment period and the expected rate of growth.

Secondary Outcome Measures

Liver transplantation

Growth over time as determined by weight in grams.

Growth over time as measured by length in cm.

Growth over time as measured by head circumference in cm.

Development of essential fatty acid (EFA) deficiency as measured by triene:tetraene ratio in those with prolonged NPO status.

Hyperlipidemia as measured by triglyceride level

Full Information

NCT ID

NCT02534077

First Posted

July 27, 2015

Last Updated

April 18, 2019

Sponsor

Pediatrix

1. Study Identification

Unique Protocol Identification Number

NCT02534077

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

April 2019 (Actual)

Study Completion Date

April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pediatrix

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Total Parenteral Nutrition-induced Cholestasis

Keywords

omegaven, cholestasis, parenteral nutrition associated liver disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Drug: Omegaven

Intervention Type

Drug

Intervention Name(s)

Omegaven

Other Intervention Name(s)

omega-3 enriched fat emulsion

Intervention Description

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

Drug

Intervention Name(s)

Omegaven

Intervention Description

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

Intervention Name(s)

Omegaven

Intervention Description

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.

Primary Outcome Measure Information:

Title

Death associated with liver disease

Description

Those patients with death only associated with liver diseasepre-treatment period and the expected rate of growth.

Time Frame

Maximum 2 years

Secondary Outcome Measure Information:

Title

Liver transplantation

Time Frame

Maximum 2 years

Title

Growth over time as determined by weight in grams.

Time Frame

Maximum 2 years

Title

Growth over time as measured by length in cm.

Time Frame

Maximum 2 years

Title

Growth over time as measured by head circumference in cm.

Time Frame

Maximum 2 years

Title

Development of essential fatty acid (EFA) deficiency as measured by triene:tetraene ratio in those with prolonged NPO status.

Time Frame

Maximum 2 years

Title

Hyperlipidemia as measured by triglyceride level

Time Frame

Maximum 2 years

Other Pre-specified Outcome Measures:

Title

Culture positive bloodstream infection

Description

Calculate the number (total and daily rate) of bloodstream infections prior to therapy, in each baby receiving Omegaven and compare with the previous rate.

Time Frame

Maximum 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Days

Maximum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaashif Ahmad, MD

Organizational Affiliation

Pediatrix

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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