Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Essential Fatty Acid Deficiency (EFAD)

Intervention / Treatment
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* Drug: Clinolipid
* Drug: Intralipid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinolipid (lipid injectable emulsion, USP) 20%<br>Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. | Drug: Clinolipid<br> <br> |
| Active Comparator: Intralipid 20% (lipid injectable emulsion, USP)<br>Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. | Drug: Intralipid<br>* Standard-of-Care Soybean Oil-Based Lipid Emulsion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Essential Fatty Acid Deficiency (EFAD) | Holman Index Calculation | Up to 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenteral Nutrition-Associated Cholestasis (PNAC) |  | Up to 90 Days | 
| Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2 |  | Baseline | 
| Fatty Acid Profile |  | Up to 90 Days | 
| Weight |  | Up to 90 Days | 
| Phytosterol, Cholesterol, and Squalene Levels |  | 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 | 
| Vital Signs |  | Up to 90 Days | 
| Adverse Events and Serious Adverse Events |  | Up to 30 Days After Subject's Last Study Treatment | 
| Clinical Laboratory Tests |  | Up to 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intralipid, Essential Fatty Acids (EFA), Parenteral Nutrition, Clinolipid/Clinoleic, Parenteral Nutrition Associated Cholestasis (PNAC), Parenteral Nutrition Associated Liver Disease (PNALD), Intestinal Failure Associated Liver Disease (IFALD), Phytosterols, Infants/Preterm Infants, FADS1 and FADS2, Short Bowel Syndrome, Cancer Nutrition, Olive Oil Emulsion, Soybean Oil Emulsion