Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

Completed · Not applicable

Conditions studied: Parenteral Nutrition-Associated Liver Disease

In brief

The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.

Key facts

Study ID

NCT01050660

Run by

Yale University

People needed

136

Starts

2009-06-01

Expected to finish

2013-01-01

Last updated by the study team

2014-10-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Preterm infants less than or equal to 29 weeks' gestation
• Age less than 48 hours

You may not qualify if…

• Congenital intrauterine infection, known to be associated with liver involvement and cholestasis
• Known structural liver abnormalities that are associated with cholestasis
• Known genetic disorders: trisomy 21, trisomy 13 and trisomy 18
• Inborn errors of metabolism
• Infants meeting the criteria for terminal illness (eg, pH < 6.8 > 2 hours)
• Inability to obtain informed consent

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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