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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

Tracking Information
First Submitted Date  ICMJE June 16, 2015
First Posted Date  ICMJE June 22, 2015
Results First Submitted Date  ICMJE October 31, 2017
Results First Posted Date  ICMJE December 5, 2017
Last Update Posted Date December 5, 2017
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
Essential Fatty Acid Deficiency (EFAD) [ Time Frame: Up to 90 Days ]
Holman Index Calculation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02476994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • Parenteral Nutrition-Associated Cholestasis (PNAC) [ Time Frame: Up to 90 Days ]
  • Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2 [ Time Frame: Baseline ]
  • Fatty Acid Profile [ Time Frame: Up to 90 Days ]
  • Weight [ Time Frame: Up to 90 Days ]
  • Phytosterol, Cholesterol, and Squalene Levels [ Time Frame: Up to 90 Days ]
  • Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin) [ Time Frame: Up to 90 Days ]
  • Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake [ Time Frame: Up to 90 Days ]
  • Vital Signs [ Time Frame: Up to 90 Days ]
  • Adverse Events and Serious Adverse Events [ Time Frame: Up to 30 Days After Subject's Last Study Treatment ]
  • Clinical Laboratory Tests [ Time Frame: Up to 90 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
  • Parenteral Nutrition-Associated Cholestasis (PNAC) [ Time Frame: Up to 90 Days ]
  • Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2 [ Time Frame: 1 Time at Screening ]
  • Fatty Acid Profile [ Time Frame: Up to 90 Days ]
  • Weight [ Time Frame: Up to 90 Days ]
  • Phytosterol, Cholesterol, and Squalene Levels [ Time Frame: Up to 90 Days ]
  • Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin) [ Time Frame: Up to 90 Days ]
  • Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake [ Time Frame: Up to 90 Days ]
  • Vital Signs [ Time Frame: Up to 90 Days ]
  • Adverse Events and Serious Adverse Events [ Time Frame: Up to 30 Days After Subject's Last Study Treatment ]
  • Clinical Laboratory Tests [ Time Frame: Up to 90 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Essential Fatty Acid Deficiency (EFAD)
Intervention  ICMJE
  • Drug: Clinolipid
  • Drug: Intralipid
    Standard-of-Care Soybean Oil-Based Lipid Emulsion
Study Arms  ICMJE
  • Experimental: Clinolipid (lipid injectable emulsion, USP) 20%
    Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.
    Intervention: 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.
    Intervention: Drug: Intralipid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 2, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2015)
100
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02476994
Other Study ID Numbers  ICMJE 6344-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxter Healthcare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Baxter Healthcare Corporation Baxter Healthcare Corporation
PRS Account Baxter Healthcare Corporation
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP