A randomized, double-blind, controlled trial for Omegaven for prophylaxis against parenteral nutrition-associated cholestasis (PNAC) in infants requiring prolonged parenteral nutrition

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-08000717

Enrollment

Unknown

Registered

2008-03-31

Start date

2008-04-30

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenteral nutrition-associated cholestasis (PNAC)

Interventions

Two groups:10% Omegaven (fish oil-based parenteral lipid supplement) 1.5 g/kg/day versus 10% Intralipid (soy-based parenteral lipid supplement) 1.5 g/kg/day, for as long as subject requires parenteral

Eligibility

Sex/Gender

All

Age

No minimum to 12 Years

Inclusion criteria

Inclusion criteria: 1. newborn infants without PNAC at the time of randomization; 2. anatomical/functional short bowel syndrome or expected to be nil by mouth for > 4 weeks; 3. informed parenteral consent.

Exclusion criteria

Exclusion criteria: 1. major congenital or lethal chromosomal abnormalities; 2. multiorgan failure imminent death; 3. cholestatic jaundice secondary to known cause other than parenteral nutrition associated cholestasis (PNAC).

Design outcomes

Secondary

Measure	Time frame
Infant growth; blood lipid profile; coagulation status; episodes of late-on infection over 4 months.;	—

Primary

Measure	Time frame
Development of PNAC over 4 months;	—

Countries

China

Contacts

Public ContactLam, Hugh Simon Hung San

Chinese University of Hong Kong

hshslam@cuhk.edu.hk+852 26322211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026