Parenteral nutrition-associated cholestasis in infants
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. developed PNAC, defined as serum conjugated bilirubin concentration >=34 mmol/L on routine weekly liver function assessment, in patients on parental nutrition; 2. expected to receive at least two more weeks of parenteral nutrition; 3. informed parental consent
Exclusion criteria
Exclusion criteria: 1. major congenital or lethal chromosomal abnormalities; 2. multiorgan failure and imminent death; 3. cholestatic jaundice secondary to other known causes e.g., congenital or acquired TORCH and syphillis infection; hepatitis B and C infection; biliary atresia and other lesions obstructing bile flow, both intrahepatic and extrahepatic
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Infant growth; blood lipid profile; coagulation status; episodes of late-onset infection over 4 months.; | — |
Primary
| Measure | Time frame |
|---|---|
| Reversal of PNAC over 4 months; | — |
Countries
China