intestinal failure and parenteral nutrition associated liver disease
Conditions
Interventions
treat with OMEGAVEN
Sponsors
Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must be enrolled in the Intestinal Rehabilitation Program at the Tohoku University Hospital, AND: Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more/clinical sign of portal hypertension, Signed patient informed consent
Exclusion criteria
Exclusion criteria: Patient (parent or guardian of child) unwilling to provide consent or assent Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program Allergies or clinical conditions precluding safe use of Omegaven
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| resolution of parenteral nutrition associated liver disease ( PNALD) as measured by normalization of serum levels of hepatic enzymes and bilirubin. optimization of nutrition status | — |
Secondary
| Measure | Time frame |
|---|---|
| progression to liver/intestinal transplant, death from liver failure | — |
Countries
Japan
Contacts
Public ContactWada Motoshi
Tohoku University School of Medicine Department of Pediatric Surgery
Outcome results
None listed