Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants

NCT02370251 Phase 2/Phase 3 COMPLETED Results posted

This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.

Details

Lead sponsor	University of Oklahoma
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	63
Start date	2015-06
Completion	2019-09-27

Conditions

• Total Parenteral Nutrition-induced Cholestasis
• Cholestasis
• Short Bowel Syndrome
• Gastroschisis
• Intestinal Atresia
• Infant, Premature, Diseases
• Cholestasis of Parenteral Nutrition

Interventions

• Omegaven

Primary outcomes

• Resolution of Cholestasis for Subjects Who Received Omegaven — Within the first 3 months of sole Omegaven use
  To determine if Omegaven results in the resolution of cholestasis (DB \<2 for 2 consecutive weeks)

Countries

United States