MedTrace Logo

Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

NCT01555957 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-12-03

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Parenteral Nutrition Associated Cholestasis

Interventions

DRUG

intravenous lipid

intravenous given daily for 6 weeks

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Sanjiv Amin, MD · University of Rochester

  • Kunal Gupta, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2018-10-30
Completion
2019-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01555957 on ClinicalTrials.gov