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

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ClinicalTrials.gov Identifier: NCT02534077
Recruitment Status : Recruiting
First Posted : August 27, 2015
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

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.

Condition or disease Intervention/treatment Phase
Total Parenteral Nutrition-induced Cholestasis Drug: Omegaven Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
Actual Study Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Drug: Omegaven
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.
Other Name: omega-3 enriched fat emulsion

Drug: 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.

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.




Primary Outcome Measures :
  1. Death associated with liver disease [ Time Frame: Maximum 2 years ]
    Those patients with death only associated with liver diseasepre-treatment period and the expected rate of growth.


Secondary Outcome Measures :
  1. Liver transplantation [ Time Frame: Maximum 2 years ]
  2. Growth over time as determined by weight in grams. [ Time Frame: Maximum 2 years ]
  3. Growth over time as measured by length in cm. [ Time Frame: Maximum 2 years ]
  4. Growth over time as measured by head circumference in cm. [ Time Frame: Maximum 2 years ]
  5. Development of essential fatty acid (EFA) deficiency as measured by triene:tetraene ratio in those with prolonged NPO status. [ Time Frame: Maximum 2 years ]
  6. Hyperlipidemia as measured by triglyceride level [ Time Frame: Maximum 2 years ]

Other Outcome Measures:
  1. Culture positive bloodstream infection [ Time Frame: Maximum 2 years ]
    Calculate the number (total and daily rate) of bloodstream infections prior to therapy, in each baby receiving Omegaven and compare with the previous rate.



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534077


Contacts
Contact: Kaashif Ahmad, MD 210-541-8281 kaashif_Ahmad@pediatrix.com

Locations
United States, Texas
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Kaashif Ahmad, MD    210-541-8281    Kaashif_Ahmad@pediatrix.com   
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Investigators
Principal Investigator: Kaashif Ahmad, MD Mednax Center for Research, Education, Quality and Safety

Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT02534077     History of Changes
Other Study ID Numbers: WIRB Study# 1155515
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Keywords provided by Mednax Center for Research, Education, Quality and Safety:
omegaven
cholestasis
parenteral nutrition associated liver disease

Additional relevant MeSH terms:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions