CompletedPhase 3

Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

United States40 participantsStarted 2012-02

Plain-language summary

The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders

Who can participate

Age range72 Hours

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. If does not need TPN by 72 hours;
✕. Direct hyperbilirubinemia within the first 72 hours after birth;
✕. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
✕. Biliary tract disorders leading to direct hyperbilirubinemia;
✕. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc

What they're measuring

Number of Participants With Parenteral Nutrition Associated Cholestasis

Timeframe: 7 weeks

Trial details

NCT IDNCT01555957

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-30

Results submitted2020-11-05

View on ClinicalTrials.gov More Parenteral Nutrition Associated Cholestasis trials