Clinical trial NCT02476994: Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
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
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-22
Enrollment: 1
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Essential Fatty Acid Deficiency (EFAD)
timeFrame: Up to 90 Days
Secondary outcomes:
measure: Parenteral Nutrition-Associated Cholestasis (PNAC)
timeFrame: Up to 90 Days
measure: Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2
timeFrame: Baseline
measure: Fatty Acid Profile
timeFrame: Up to 90 Days
measure: Weight
timeFrame: Up to 90 Days
measure: Phytosterol, Cholesterol, and Squalene Levels
timeFrame: Up to 90 Days
measure: Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)
timeFrame: Up to 90 Days
measure: Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake
timeFrame: Up to 90 Days
measure: Vital Signs
timeFrame: Up to 90 Days
measure: Adverse Events and Serious Adverse Events
timeFrame: Up to 30 Days After Subject's Last Study Treatment
measure: Clinical Laboratory Tests
timeFrame: Up to 90 Days
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children at Indiana Health
state: Indiana
city: Columbus
country: United States
facility: Ohio State University, Wexner Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of SC, Neonatology
state: South Carolina
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter Healthcare Corporation
role: STUDY_DIRECTOR
References: