Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants

What is the purpose of this trial?

To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.


Participation Guidelines

Gender: Both


Fresenius Kabi DEutschland GmbH

Dates: 07/07/2017 - 10/31/2017

Last Updated: 07/19/2017

Study HIC#: 1510016597

Get Involved

For more information about this study, contact:
Elaine Romano
203-688-2320
elaine.romano@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Orly Levit

Principal Investigator

Sub-Investigators