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

Essential Fatty Acid Deficiency (EFAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02476994
• Other study ID #: 6344-001
• Status: Terminated
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: October 2016

Study information

• Verified date: July 2021
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Fatty Acid Deficiency (EFAD)

Intervention

Drug:
• Clinolipid

• Intralipid
Standard-of-Care Soybean Oil-Based Lipid Emulsion

Locations

Country	Name	City	State
United States	Medical University of SC, Neonatology	Charleston	South Carolina
United States	Ohio State University, Wexner Medical Center	Columbus	Ohio
United States	Riley Hospital for Children at Indiana Health	Indianapolis	Indiana
United States	Advocate Children's Hospital	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

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