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

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ClinicalTrials.gov Identifier: NCT02476994
Recruitment Status : Terminated (Based on feedback from FDA)
First Posted : June 22, 2015
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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.

Condition or disease Intervention/treatment Phase
Essential Fatty Acid Deficiency (EFAD) Drug: Clinolipid Drug: Intralipid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Essential Fatty Acid Deficiency (EFAD) [ Time Frame: Up to 90 Days ]
    Holman Index Calculation


Secondary Outcome Measures :
  1. Parenteral Nutrition-Associated Cholestasis (PNAC) [ Time Frame: Up to 90 Days ]
  2. Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2 [ Time Frame: Baseline ]
  3. Fatty Acid Profile [ Time Frame: Up to 90 Days ]
  4. Weight [ Time Frame: Up to 90 Days ]
  5. Phytosterol, Cholesterol, and Squalene Levels [ Time Frame: Up to 90 Days ]
  6. Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin) [ Time Frame: Up to 90 Days ]
  7. Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake [ Time Frame: Up to 90 Days ]
  8. Vital Signs [ Time Frame: Up to 90 Days ]
  9. Adverse Events and Serious Adverse Events [ Time Frame: Up to 30 Days After Subject's Last Study Treatment ]
  10. Clinical Laboratory Tests [ Time Frame: Up to 90 Days ]


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476994


Locations
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United States, Illinois
Advocate Children's Hospital
Park Ridge, Illinois, United States, 60068
United States, Indiana
Riley Hospital for Children at Indiana Health
Indianapolis, Indiana, United States, 46202
United States, Ohio
Ohio State University, Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of SC, Neonatology
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Study Director: Baxter Healthcare Corporation Baxter Healthcare Corporation

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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02476994     History of Changes
Other Study ID Numbers: 6344-001
First Posted: June 22, 2015    Key Record Dates
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: October 2017
Keywords provided by Baxter Healthcare Corporation:
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
Additional relevant MeSH terms:
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Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions