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The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

NCT03857646 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-03-03

Study results available
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Summary

The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.

Conditions

  • Prematurity

Interventions

DRUG

Intralipid, 20% Intravenous Emulsion

Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.

DRUG

Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid

Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Cody Arnold, MD · UT Houston HSC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
8 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-02
Primary Completion
2020-06-11
Completion
2020-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03857646 on ClinicalTrials.gov