Status:
COMPLETED
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Cholestasis
Cholestasis of Parenteral Nutrition
Eligibility:
All Genders
14-5 years
Phase:
NA
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 alterna...
Detailed Description
Inpatient Use of Omegaven: Each family will have the severity of their child's condition explained to them and the available data regarding the benefit of the novel preparation explained using the pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2020
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00738101
Start Date
September 1 2008
End Date
March 27 2020
Last Update
May 28 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030