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

NCT ID: NCT02476994

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-10-31

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.

Conditions

Essential Fatty Acid Deficiency (EFAD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Clinolipid (lipid injectable emulsion, USP) 20%

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

Group Type: EXPERIMENTAL

Clinolipid

Intervention Type: DRUG

Intralipid 20% (lipid injectable emulsion, USP)

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

Group Type: ACTIVE_COMPARATOR

Intralipid

Intervention Type: DRUG

Standard-of-Care Soybean Oil-Based Lipid Emulsion

Interventions

Clinolipid

Intervention Type: DRUG

Intralipid

Standard-of-Care Soybean Oil-Based Lipid Emulsion

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baxter Healthcare Corporation

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

Advocate Children's Hospital

Park Ridge, Illinois, United States

Riley Hospital for Children at Indiana Health

Indianapolis, Indiana, United States

Ohio State University, Wexner Medical Center

Columbus, Ohio, United States

Medical University of SC, Neonatology

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

6344-001

Identifier Type: -

Identifier Source: org_study_id