A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid (Lipid Injectable Emulsion, USP) 20% or Standard-of-Care Soybean Oil-Based Lipid Emulsion

Baxter Healthcare Corporation4 sites in 1 country1 target enrollmentMay 2015

ConditionsEssential Fatty Acid Deficiency (EFAD)

InterventionsClinolipid Intralipid

DrugsClinolipid Intralipid

Overview

Phase: Phase 4
Intervention: Clinolipid
Conditions: Essential Fatty Acid Deficiency (EFAD)
Sponsor: Baxter Healthcare Corporation
Enrollment: 1
Locations: 4
Primary Endpoint: Essential Fatty Acid Deficiency (EFAD)
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

October 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF
•Patients age \<18 years
•Patients who are able to adhere to protocol requirements
•Patients who are expected to require PN for at least 7 days
•Premature infants (\<36 weeks of gestation) require at least 80% PN to meet nutrition requirements at study entry; full term infants and children require at least 70% PN to meet nutrition requirements at study entry

Exclusion Criteria

•Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study
•Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
•Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH \<7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap \>16 mEq/L)
•Patients with hemodynamic instability as judged by the Investigator
•Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
•Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride \>400 mg/dL)
•Patients who are unable to tolerate the necessary laboratory monitoring
•Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment
•Patients who are enrolled in another clinical trial involving an investigational agent
•Patients who were treated with IV lipids within 48 hours of randomization into the study

Arms & Interventions

Clinolipid (lipid injectable emulsion, USP) 20%

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intervention: Clinolipid

Intralipid 20% (lipid injectable emulsion, USP)

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intervention: Intralipid

Outcomes

Primary Outcomes

Essential Fatty Acid Deficiency (EFAD)

Time Frame: Up to 90 Days

Holman Index Calculation

Secondary Outcomes

Parenteral Nutrition-Associated Cholestasis (PNAC)(Up to 90 Days)
Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2(Baseline)
Phytosterol, Cholesterol, and Squalene Levels(Up to 90 Days)
Vital Signs(Up to 90 Days)
Adverse Events and Serious Adverse Events(Up to 30 Days After Subject's Last Study Treatment)
Fatty Acid Profile(Up to 90 Days)
Weight(Up to 90 Days)
Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)(Up to 90 Days)
Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake(Up to 90 Days)
Clinical Laboratory Tests(Up to 90 Days)