Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
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|ClinicalTrials.gov Identifier: NCT02534077|
Recruitment Status : Recruiting
First Posted : August 27, 2015
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Total Parenteral Nutrition-induced Cholestasis||Drug: Omegaven||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants|
|Actual Study Start Date :||August 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
Other Name: omega-3 enriched fat emulsion
Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 2 years.
If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.
- Death associated with liver disease [ Time Frame: Maximum 2 years ]Those patients with death only associated with liver diseasepre-treatment period and the expected rate of growth.
- Liver transplantation [ Time Frame: Maximum 2 years ]
- Growth over time as determined by weight in grams. [ Time Frame: Maximum 2 years ]
- Growth over time as measured by length in cm. [ Time Frame: Maximum 2 years ]
- Growth over time as measured by head circumference in cm. [ Time Frame: Maximum 2 years ]
- Development of essential fatty acid (EFA) deficiency as measured by triene:tetraene ratio in those with prolonged NPO status. [ Time Frame: Maximum 2 years ]
- Hyperlipidemia as measured by triglyceride level [ Time Frame: Maximum 2 years ]
- Culture positive bloodstream infection [ Time Frame: Maximum 2 years ]Calculate the number (total and daily rate) of bloodstream infections prior to therapy, in each baby receiving Omegaven and compare with the previous rate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534077
|Contact: Kaashif Ahmad, MD||210-541-8281||kaashif_Ahmad@pediatrix.com|
|United States, Texas|
|Children's Hospital of San Antonio||Recruiting|
|San Antonio, Texas, United States, 78207|
|Contact: Kaashif Ahmad, MD 210-541-8281 Kaashif_Ahmad@pediatrix.com|
|Principal Investigator:||Kaashif Ahmad, MD||Mednax Center for Research, Education, Quality and Safety|