Trial Outcomes & Findings for Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease (NCT NCT00862446)

Results Overview

Defined as direct bilirubin \<2.0 mg/dL

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

At discharge or up to 10 weeks

Results posted on

2021-01-05

Participant milestones
Measure	Omegaven Treatment All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Omegaven Treatment n=48 Participants All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
Age, Continuous	63.875 days STANDARD_DEVIATION 32.25 • n=48 Participants
Sex: Female, Male Female	22 Participants n=48 Participants
Sex: Female, Male Male	26 Participants n=48 Participants
Region of Enrollment United States	48 participants n=48 Participants
Direct Bilirubin	6.25 mg/dL STANDARD_DEVIATION 3.83 • n=48 Participants

Timeframe: At discharge or up to 10 weeks

Defined as direct bilirubin \<2.0 mg/dL

Outcome measures
Measure	Omegaven Treatment n=48 Participants All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
Number of Participants With Resolution of the Direct Hyperbilirubinemia	29 Participants

Serious events: 5 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events
Measure	Omegaven Treatment n=48 participants at risk All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally
Blood and lymphatic system disorders Coagulopathy	2.1% 1/48 • Number of events 1 • Baseline to Week 10 The only adverse collected were mortality, coagulopathy, hypertriglyceridemia
Blood and lymphatic system disorders Hypertriglyceridemia	10.4% 5/48 • Number of events 5 • Baseline to Week 10 The only adverse collected were mortality, coagulopathy, hypertriglyceridemia

Adverse event data not reported

Vanderbilt University Medical Center

Phone: 615-322-3476