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Trial record 3 of 3731 for:    Indiana Health

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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT02476994
First received: June 16, 2015
Last updated: May 17, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
Essential Fatty Acid Deficiency (EFAD)
Drug: Clinolipid
Drug: Intralipid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Essential Fatty Acid Deficiency (EFAD) [ Time Frame: Up to 90 Days ] [ Designated as safety issue: Yes ]
    Holman Index Calculation


Secondary Outcome Measures:
  • Parenteral Nutrition-Associated Cholestasis (PNAC) [ Time Frame: Up to 90 Days ] [ Designated as safety issue: Yes ]
  • Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2 [ Time Frame: 1 Time at Screening ] [ Designated as safety issue: No ]
  • Fatty Acid Profile [ Time Frame: Up to 90 Days ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: Up to 90 Days ] [ Designated as safety issue: No ]
  • Phytosterol, Cholesterol, and Squalene Levels [ Time Frame: Up to 90 Days ] [ Designated as safety issue: No ]
  • Change from Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin) [ Time Frame: Up to 90 Days ] [ Designated as safety issue: Yes ]
  • Prescribed and Actual (Total Calories from PN and Oral) Nutritional Intake [ Time Frame: Up to 90 Days ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: Up to 90 Days ] [ Designated as safety issue: No ]
  • Adverse Events and Serious Adverse Events [ Time Frame: Up to 30 Days After Subject's Last Study Treatment ] [ Designated as safety issue: Yes ]
  • Clinical Laboratory Tests [ Time Frame: Up to 90 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2015
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02476994

Locations
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
Study Director: Baxter Healthcare Corporation Baxter Healthcare Corporation
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02476994     History of Changes
Other Study ID Numbers: 6344-001 
Study First Received: June 16, 2015
Last Updated: May 17, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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:
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on December 02, 2016