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

Phase 4

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Clinolipid (lipid injectable emulsion, USP) 20%	Clinolipid	Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.
Intralipid 20% (lipid injectable emulsion, USP)	Intralipid	Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Primary Outcome Measures

Name	Time	Method
Essential Fatty Acid Deficiency (EFAD)	Up to 90 Days	Holman Index Calculation

Secondary Outcome Measures

Name	Time	Method
Parenteral Nutrition-Associated Cholestasis (PNAC)	Up to 90 Days
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
Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2	Baseline
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

Locations (4): Riley Hospital for Children at Indiana Health
🇺🇸
Indianapolis, Indiana, United States
Ohio State University, Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
Advocate Children's Hospital
🇺🇸
Park Ridge, Illinois, United States
Medical University of SC, Neonatology
🇺🇸
Charleston, South Carolina, United States