Parenteral Nutrition Associated Cholestasis
Conditions
Keywords
cholestasis, PNAC, Parenteral Nutrition Associated Cholestasis, PNALD, Parenteral Nutrition Associated Liver Disease
Brief summary
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
Interventions
DRUGOmegaven
1 g/kg/d iv infusion over 24h
Sponsors
Arthur J De Lorimier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
Cholestasis defined as either * serum bilirubin \> 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR * serum bilirubin \> 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis
Exclusion criteria
* Age \> 1y at time that omegaven is started * Not expected to survive at least 30 days * Fish allergy in a first degree relative * Hemodynamic instability * Coagulopathy * Not likely to require PN for \> 30d * Not expected to survive \> 30d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) | approximately for 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Liver Transaminases | approximately for 4 months |
Countries
United States
Participant flow
Recruitment details
Started Omegaven: N=12 1 Died of complications not related to omegavin 5 Weaned off PN before DC (2F, 3M) 6 Discharged Home on PN (of these 3 remain on PN\[all male\]; 3 weaned off after DC \[2M, 1F\])
Participants by arm
| Arm | Count |
|---|---|
| Omeagven Omegaven: 1 g/kg/d iv infusion over 24h | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Omeagven | — |
|---|---|---|
| Age, Continuous | 10 month STANDARD_DEVIATION 1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
Time frame: approximately for 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omeagven | Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) | 2 mg/dl | Standard Deviation 0.2 |
Secondary
Liver Transaminases
Time frame: approximately for 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omeagven | Liver Transaminases | 98 mg/dl | Standard Deviation 10 |