To provide Omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis
An intermediate population, Investigational New Drug study, to provide an alternate intravenous fat nutrition, Omegaven®, to help improve liver function while providing adequate nutrition for critically ill infants with parenteral nutrition associated cholestasis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Omegaven® fat emulsion will be used as a compassionate use treatment for critically ill infants with parenteral nutrition associated liver injury
USF Health
Tampa, Florida, United States
Number of Participant With Decrease in Direct Bilirubin Level
Number of participant with decrease in direct bilirubin levels within 30 days of treatment
Time frame: First month of treatment
Number of Participant With Resolution of Direct Hyperbilirubinemia
Number of participant with Direct bilirubin level of \<2mg/dL at discontinuation of treatment
Time frame: 2 months
Number of Participant With Preservation of Length
Monitoring of weekly length while the patient is receiving Omegaven® treatment
Time frame: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment
Number of Participant With Preservation of Head Circumference
Monitoring of weekly head circumference while the patient is receiving Omegaven® treatment
Time frame: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment
Number of Participant With Preservation of Normal Weight Gain
Monitoring of daily weight gain while the patient is on Omegaven®
Time frame: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment
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