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 (Part A)
Overview
- Phase
- Phase 4
- Intervention
- Clinolipid
- Conditions
- Essential Fatty Acid Deficiency (EFAD)
- Sponsor
- Baxter Healthcare Corporation
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid or Intralipid in a pediatric population.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients and/or their legal representative must be able to understand the study and voluntarily sign the informed consent form (ICF) per 21 CFR Part 50.55(e)
- •Patients and/or their legal representative accept adherence to protocol requirements
- •Patients who are expected to require parenteral nutrition (PN)for at least 7 days
- •Premature infants (born at 24 to \<37 weeks of gestation with a birth weight ≥750g) require at least 80% of targeted energy requirements by PN at study entry (up to 1 month CA); full term infants and children require at least 70% of targeted energy requirements by PN at study entry
Exclusion Criteria
- •Patients who are not expected to survive hospitalization or with a severe critical unresponsive illness at time of initiation with foreseeable intercurrent events that could jeopardize the patient's participation in the study, as judged by the Investigator (e.g., unresponsive shock, sepsis, renal failure requiring dialysis, severe unresponsive metabolic acidosis, and/or severe unresponsive metabolic disorders);
- •Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container or who have a history of an adverse event due to ILE;
- •Patients with 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 are enrolled in another clinical trial involving an investigational agent;
- •Patients with a known history of either severe hemorrhagic or severe hemolytic disease as judged by the investigator;
- •Premature infants born \<24 weeks of gestation and patients ≥18 years;
- •Premature infants with a birth weight \<750 g;
- •Patient requires or is expected to require propofol for sedation;
Arms & Interventions
Clinolipid
Dosing based on American Academy of Pediatrics (AAP), American Academy Society for Parenteral and Enteral Nutrition (ASPEN), European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN)/ European Society for Parenteral and Enteral Nutrition (ESPEN)/ European Society of Paediatric Research (ESPR)/ Chinese Society for Parenteral and Enteral Nutrition (CSPEN) guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours.
Intervention: Clinolipid
Intralipid
Dosing based on AAP, ASPEN, ESPGHAN/ESPEN/ESPR/CSPEN guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours.
Intervention: Intralipid
Outcomes
Primary Outcomes
Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4
Time Frame: Up to Day 90
Holman Index is the plasma Triene:Tetraene ratio, specifically 5,8,11-eicosatrienoic acid \[mead acid\] to 5,8,11,14 eicosatetraenoic acid \[arachidonic acid, \[ARA\] ratio
Secondary Outcomes
- Calories Nutritional Intake(Up to Day 90)
- Direct Bilirubin(Up to Day 90)
- Gamma-Glutamyl Transferase (GGT)(Up to Day 90)
- Campesterol Blood Level(Up to Day 90)
- Total Bilirubin(Up to Day 90)
- Sitosterol Blood Level(Up to day 90)
- Squalene Blood Level(Up to Day 90)
- Protein Nutritional Intake(Up to Day 90)
- Alkaline Phosphatase (ALP)(Up to Day 90)
- Number of Adverse Events of Special Interest(Up to Day 120 (30 Days After Subject's Last Study Treatment if hospital discharge has not occurred))
- Aspartate Aminotransferase (AST)(Up to Day 90)
- Alanine Aminotransferase (ALT)(Up to Day 90)
- Lipid Nutritional Intake(Up to Day 90)
- Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD)(Up to Day 90)
- Stigmasterol Blood Level(Up to Day 90)
- Cholesterol Blood Level(Up to Day 90)
- Carbohydrates Nutritional Intake(Up to Day 90)
- Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline(Up to Day 90)
- Body Weight(Upto Day 90)
- Number of Participants With Neonatal Morbidities(Up to Day 90)