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
Study Type
OBSERVATIONAL
Enrollment
40
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
Memorial Health Service
Fountain Valley, California, United States
RECRUITINGUniversity of California Los Angeles
Los Angeles, California, United States
RECRUITINGIncidence 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
Incidence of clinical EFAD
Clinical EFAD is defined by clinical symptoms (like dry, scaly rash, hair loss, hair depigmentation, poor wound healing, growth restriction, and increased susceptibility to infection) and T:T ratio ≥ 0.083
Time frame: Up to week 56
Time from treatment start to EFAD diagnosis
Time from treatment start to EFAD diagnosis
Time frame: Up to week 56
Incidence of adverse events (AEs)/serious adverse events (SAEs)
The incidence of AEs/SAEs considered by the Investigator to be related to study treatment
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Chicago
Chicago, Illinois, United States
RECRUITINGChildren's Hospital Corporation d/b/a Boston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGChildren's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGBoard of Regents of the University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGBaylor College of Medicine Houston
Houston, Texas, United States
RECRUITINGThe University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
RECRUITINGSeattle Children's Hospital d/b/a Seattle Children's Research Institute
Seattle, Washington, United States
RECRUITINGFatty 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