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

• Status: Completed
• Trial end date: 2020-03-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborators: Boston Children's Hospital; Boston Children’s Hospital

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.