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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-02

Study Completion Date

2020-06-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intralipid

Group Type OTHER

Intralipid, 20% Intravenous Emulsion

Intervention Type DRUG

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.

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

Group Type OTHER

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* premature newborns (\<32 weeks gestation, stratified \<28 weeks versus \>28 weeks) \<8 days of age
* receiving lipid infusions \<1 g/kg/day at enrollment
* anticipated to be treated with 3 g/kg/day for a minimum of 48 hours.

Exclusion Criteria

* patients with direct hyperbilirubinemia \>1.5 mg/dl
* with suspected sepsis meeting Systemic inflammatory response syndrome (SIRS) criteria
* undergoing treatment with a continuous infusion of morphine
* with a continuous infusion of pressors (dopamine, dobutamine, epinephrine, etc.)
* positive blood cultures

Minimum Eligible Age

0 Days

Maximum Eligible Age

8 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No