Clinical trialNCT02357576CompletedPhase 3Interventional

Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

SponsorUniversity of MichiganEnrollment22Cholestasis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions. Much research is currently being directed at identifying ways to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of parenteral nutrition is one possible strategy. In this study we will compare standard dosing of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for the development of cholestasis and adequate growth between the two groups. Longterm followup will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age. Funding source - FDA OOPD

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Meghan A Arnold, MD
University of Michigan
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Colorado/children'S Hospital Colorado
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Primary Children'S Hospital
Salt Lake City, Utah, United States
Seattle Children'S Hospital
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Intralipid 20% I.V. Fat Emulsion

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 May 2016
Primary completion: 12 Oct 2017
Completion: 8 Nov 2019
Last update posted: 17 Dec 2020
Registered enrollment: 22
Registry id: NCT02357576

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Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.