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

NCT02476994 | Terminated Phase 4 Results DMC

• 1 other identifier: 6344-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 4

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)

Keywords

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; Intralipid; Infants/Preterm Infants; FADS1 and FADS2; Short Bowel Syndrome; Cancer Nutrition; Olive Oil Emulsion; Soybean Oil Emulsion

Outcome Measures

Primary Outcomes (1)

• Essential Fatty Acid Deficiency (EFAD)

  Holman Index Calculation

  Up to 90 Days

Secondary Outcomes (10)

• 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

Study Arms (2)

Clinolipid (lipid injectable emulsion, USP) 20%

EXPERIMENTAL

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

Drug: Clinolipid

Intralipid 20% (lipid injectable emulsion, USP)

ACTIVE COMPARATOR

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

Drug: Intralipid

Interventions

Clinolipid DRUG

Clinolipid (lipid injectable emulsion, USP) 20%

Intralipid DRUG

Standard-of-Care Soybean Oil-Based Lipid Emulsion

Intralipid 20% (lipid injectable emulsion, USP)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (4)

Advocate Children's Hospital

Park Ridge, Illinois, 60068, United States

Location

Riley Hospital for Children at Indiana Health

Indianapolis, Indiana, 46202, United States

Location

Ohio State University, Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Medical University of SC, Neonatology

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hyperphagia; Pena Shokeir syndrome, type 1; Short Bowel Syndrome

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Clinical Trials Disclosure Group
• Organization: Baxter Healthcare

joe_archer@baxter.com

Study Officials

• Baxter Healthcare Corporation

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 22, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 21, 2021
• Results First Posted: December 5, 2017

Record last verified: 2021-07

Locations

US (4)