Title: A Single-arm, Open-label, Prospective, Multicenter Safety Study to Evaluate the Occurrence of Essential Fatty Acid Deficiency (EFAD) in Pediatric Patients With Parenteral Nutrition-associated Cholestasis (PNAC) Who Require More Than Eight Weeks of Omegaven Treatment
Summary
This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
Arms & interventions
- DrugOmegaven® (fish oil triglycerides) Injectable Emulsion
Pediatric patients Pediatric patients with new-onset PNAC Drug: Omegaven® (fish oil triglycerides) Injectable Emulsion Dose, frequency and duration is a decision of the Investigator
Outcome measures
Primary
Incidence of essential fatty acid deficiency (EFAD)
EFAD as defined by the triene:tetraene (T:T) ratio; severity of EFAD will be graded and analysed based on T:T ratio (suspected ≥ 0.05, moderate ≥ 0.20, and severe ≥ 0.40)
Time frame: Up to week 56
Secondary
Incidence of clinical EFAD
Time frame: Up to week 56
Time from treatment start to EFAD diagnosis
Time frame: Up to week 56
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Up to week 56
Routine laboratory tests: Direct or conjugated bilirubin
Time frame: Up to week 56
Routine laboratory tests: triglycerides
Time frame: Up to week 56
Fatty acid profiles: α-linolenic acid
Time frame: Up to week 56
Fatty acid profiles: linoleic acid
Time frame: Up to week 56
Fatty acid profiles: arachidonic acid
Time frame: Up to week 56
Fatty acid profiles: mead acid
Time frame: Up to week 56
Fatty acid profiles: oleic acid
Time frame: Up to week 56
Fatty acid profiles: docosahexaenoic acid (DHA)
Time frame: Up to week 56
Fatty acid profiles: eicosapentaenoic acid (EPA)
Time frame: Up to week 56
Anthropometric measures: body weight
Time frame: Up to week 56
Anthropometric measures: body height/length
Time frame: Up to week 56
Anthropometric measures: head circumference
Time frame: Up to week 56
Eligibility criteria
Study locations (10)
Memorial Health Service
Fountain Valley, California, 92708
University of California Los Angeles
Los Angeles, California, 10911
The University of Chicago
Chicago, Illinois, 60637
Children's Hospital Corporation d/b/a Boston Children's Hospital
Boston, Massachusetts, 02115
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Board of Regents of the University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Baylor College of Medicine Houston
Houston, Texas, 77030
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3901
Seattle Children's Hospital d/b/a Seattle Children's Research Institute
Seattle, Washington, 98105