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

Completed · Not applicable

Conditions studied: Cholestasis, Cholestasis of Parenteral Nutrition

In brief

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.

Key facts

Study ID

NCT00738101

Run by

Baylor College of Medicine

People needed

293

Starts

2008-09-01

Expected to finish

2020-03-27

Last updated by the study team

2021-05-28

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Baylor College of Medicine — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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