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

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

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.

Study Overview

• Status: Terminated
• Conditions: Essential Fatty Acid Deficiency (EFAD)
• Intervention / Treatment: Drug: Clinolipid; Drug: Intralipid

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Children's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children at Indiana Health
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University, Wexner Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of SC, Neonatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF
2. Patients age <18 years
3. Patients who are able to adhere to protocol requirements
4. Patients who are expected to require PN for at least 7 days
5. 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:

1. 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
2. Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
3. 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)
4. Patients with hemodynamic instability as judged by the Investigator
5. Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
6. Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride >400 mg/dL)
7. Patients who are unable to tolerate the necessary laboratory monitoring
8. Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment
9. Patients who are enrolled in another clinical trial involving an investigational agent
10. Patients who were treated with IV lipids within 48 hours of randomization into the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Study Director: Baxter Healthcare Corporation, Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimate): June 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Parenteral Nutrition; Intralipid; Phytosterols; Short Bowel Syndrome; Essential Fatty Acids (EFA); Clinolipid/Clinoleic; Parenteral Nutrition Associated Cholestasis (PNAC); Parenteral Nutrition Associated Liver Disease (PNALD); Intestinal Failure Associated Liver Disease (IFALD); Infants/Preterm Infants; FADS1 and FADS2; Cancer Nutrition; Olive Oil Emulsion; Soybean Oil Emulsion
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: 6344-001