Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00738101
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
Boston Children's Hospital
Information provided by (Responsible Party):
Muralidhar Premkumar, Baylor College of Medicine

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
Cholestasis Cholestasis of Parenteral Nutrition Drug: Omegaven Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 293 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Initiation of Study is defined as the day the Fish Oil Emulsion was initiated.

End of Study (EOS) is defined as discontinuation of fish oil emulsion, death, transplant, or discharge from the hospital.

In infants who meet the eligibility criteria for Fish Oil Emulsion arm will receive Fish Oil Emulsion after enrollment under the study. Therapy with Fish Oil Emulsion (Omegaven) will be provided at a dose of 1 gm/kg/day (by continuous infusion) and will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If previously on Intralipid, it will be stopped prior to initiation of Fish Oil Emulsion.

Masking: None (Open Label)
Masking Description: 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
Study Start Date : September 2008
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : March 27, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Fish Oil Emulsion Arm

In infants who meet the eligibility criteria for Fish Oil Emulsion arm will receive Fish Oil Emulsion after enrollment under the study.

Therapy with Fish Oil Emulsion (Omegaven) will be provided at a dose of 1 gm/kg/day (by continuous infusion) and will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If previously on Intralipid, it will be stopped prior to initiation of Fish Oil Emulsion.Fish oil emulsion will be provided as a continuous intravenous emulsion over 24 hours.

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. 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 5 years. If the infant no longer is requiring any TPN, then the Omegaven will be stopped regardless of bilirubin. 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.
Other Name: Omega-3 enriched fat emulsion




Primary Outcome Measures :
  1. Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study [ Time Frame: From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). ]
    Time in days from the initiation of fish oil emulsions (initiation of study) until resolution of cholestasis as defined by serum conjugated bilirubin≤ 2 mg/dL prior to EOS (end of study).

  2. All Cause Mortality During the Study. [ Time Frame: From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). ]
    To describe proportion of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion.

  3. Growth Z-scores for Weight [ Time Frame: From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). ]
    The Z-score indicated the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean. A weight Z-score of ≤ -2 indicates an underweight status, while a weight Z-score of ≥ 2 indicates overweight or obese status.


Secondary Outcome Measures :
  1. Number of Infants Who Achieve Resolution of Parenteral Nutrition Associated Cholestasis [ Time Frame: From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). ]
    To describe the number of infants who achieved resolution of cholestasis following initiation of fish oil emulsion.

  2. Number of Subjects With Platelet Count <100,000/µL [ Time Frame: From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). ]
    To describe the number of study subjects who experienced a platelet count below <100,000/µL anytime during the duration of the study.

  3. Number of Subjects With INR ≥1.4. [ Time Frame: From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). ]
    To describe the number of study subjects who experienced an INR ≥1.4 anytime during the duration of the study.

  4. Number of Study Subjects Who Experienced a Blood Stream Infection [ Time Frame: From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). ]

    To describe the number of study subjects who experienced a bloodstream infection during the duration of the study.

    Bloodstream infection as defined by detection by the culture of bacteria or fungus from the blood.


  5. Liver or Multi-visceral Transplant [ Time Frame: From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). ]
    To describe the number and percentage of infants who required liver or multi-visceral transplant.

  6. All-cause Mortality up to Hospital Discharge [ Time Frame: Anytime from initiation of study to discharge from the hospital. ]
    To describe number and percentage of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be greater than 14 days old and less than 5 years old
  • Conjugated bilirubin greater than 2 mg/dL.
  • Be expected to require intravenous nutrition for at least an additional 28 days

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.

Home Use of Omegaven®:

In order for a subject to receive the Omegaven® at home through a home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®.

If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic.

Outpatient Monitoring:

After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team.


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): NCT00738101


Locations
Layout table for location information
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Boston Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Murali Premkumar, MD Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Muralidhar Premkumar, Baylor College of Medicine:
Informed Consent Form  [PDF] November 20, 2017

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Muralidhar Premkumar, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00738101    
Other Study ID Numbers: H-23365
First Posted: August 20, 2008    Key Record Dates
Results First Posted: May 21, 2020
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Please see the IPD sharing section below.
Keywords provided by Muralidhar Premkumar, Baylor College of Medicine:
Omega-3
Omegaven
Cholestasis
Liver damage
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases