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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Baylor College of Medicine
Children's Hospital Boston
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine Identifier:
First received: August 18, 2008
Last updated: June 6, 2014
Last verified: June 2014

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 Intervention
Parenteral Nutrition
Drug: Omegaven

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Maximum 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: September 2008
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. 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

  Show Detailed Description


Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be greater than 14 days old and less than 5 years old
  • 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
  • Be receiving at least 60% of their calories by intravenous infusion
  • 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00738101

Contact: Steve A Abrams, MD 713-798-7124
Contact: Keli M Hawthorne, MS, RD 713-798-7085

United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Keli M Hawthorne, MS, RD    713-798-7085   
Sub-Investigator: Beth A Carter, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Keli M Hawthorne, MS, RD    713-798-7085   
Sub-Investigator: Beth A Carter, MD         
Sponsors and Collaborators
Baylor College of Medicine
Children's Hospital Boston
Principal Investigator: Steve A Abrams, MD Baylor College of Medicine
  More Information


Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine Identifier: NCT00738101     History of Changes
Other Study ID Numbers: H-23365
Study First Received: August 18, 2008
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Liver damage

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on November 24, 2014