NCT02370251 - Compassionate Use of Omegaven in Children | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

September 27, 2018

Study Completion Date

September 27, 2019

Conditions

Total Parenteral Nutrition-induced CholestasisCholestasisShort Bowel SyndromeGastroschisisIntestinal AtresiaInfant, Premature, DiseasesCholestasis of Parenteral Nutrition

Interventions

DRUG

Omegaven

Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \<2 mg/dL) occurs.

Trial Locations (1)

73104

OU Children's Hospital, Oklahoma City