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Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

NCT02357576 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-12-17

Study results available
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Summary

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

Conditions

  • Cholestasis

Interventions

DRUG

Intralipid 20% I.V. Fat Emulsion

Sponsors & Collaborators

  • Seattle Children's Hospital

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • Primary Children's Hospital

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • University of Michigan

    lead OTHER

Principal Investigators

  • Meghan A Arnold, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-21
Primary Completion
2017-10-12
Completion
2019-11-08

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02357576 on ClinicalTrials.gov