Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

RecruitingOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

December 15, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2027

Conditions
Parenteral Nutrition Associated Liver Disease (PNALD)Essential Fatty Acid DeficiencyMalnutritionPediatric ALL
Interventions
DRUG

Omegaven® (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"

Trial Locations (10)

10911

RECRUITING

University of California Los Angeles, Los Angeles

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

45229

RECRUITING

Children's Hospital Medical Center, Cincinnati

60637

RECRUITING

The University of Chicago, Chicago

73104

RECRUITING

Board of Regents of the University of Oklahoma Health Sciences Center, Oklahoma City

77030

RECRUITING

Baylor College of Medicine Houston, Houston

92708

RECRUITING

Memorial Health Service, Fountain Valley

98105

RECRUITING

Seattle Children's Hospital d/b/a Seattle Children's Research Institute, Seattle

02115

RECRUITING

Children's Hospital Corporation d/b/a Boston Children's Hospital, Boston

78229-3901

RECRUITING

The University of Texas Health Science Center at San Antonio, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Fresenius Kabi

INDUSTRY