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

NCT ID: NCT04555044

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2022-11-16

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Clinolipid

Intervention Type: DRUG

Lipid injectable emulsion, USP 20%

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.

Group Type: ACTIVE_COMPARATOR

Intralipid

Intervention Type: DRUG

Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)

Interventions

Clinolipid

Lipid injectable emulsion, USP 20%

Intervention Type: DRUG

Intralipid

Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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)

2. Patients and/or their legal representative accept adherence to protocol requirements

3. Patients who are expected to require parenteral nutrition (PN)for at least 7 days

4. 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

1. 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);

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 or who have a history of an adverse event due to ILE;

3. Patients with liver disease including cholestasis;

4. Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride >400 mg/dL);

5. Patients who are unable to tolerate the necessary laboratory monitoring;

6. Patients who are enrolled in another clinical trial involving an investigational agent;

7. Patients with a known history of either severe hemorrhagic or severe hemolytic disease as judged by the investigator;

8. Premature infants born <24 weeks of gestation and patients ≥18 years;

9. Premature infants with a birth weight <750 g;

10. Patient requires or is expected to require propofol for sedation;

11. Patient has received a diagnosis of Coronavirus Disease of 2019 (COVID-19) (diagnosis <2 months prior and/or symptoms have not resolved.

12. Newborn patient born to a mother who was diagnosed as COVID-19 positive at delivery or within 2 months prior to delivery

13. Female patients who are pregnant. Note: All female patients ≥12 years of age must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at screening. For female patients <12 years of age, a urine hCG test at screening will be performed at the discretion of the investigator based on childbearing potential.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baxter Healthcare Corporation

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

Baxter Investigational Site

Mobile, Alabama, United States

Baxter Investigational Site

New Haven, Connecticut, United States

Baxter Investigational Site

Orlando, Florida, United States

Baxter Investigational Site

Boston, Massachusetts, United States

Baxter Investigational Site

Jackson, Mississippi, United States

Baxter Investigational Site

Greenville, North Carolina, United States

Baxter Investigational Site

Memphis, Tennessee, United States

Baxter Investigational Site

San Antonio, Texas, United States

Baxter Investigational Site

Provo, Utah, United States

Countries

United States

References

Blanco C, Chang W, Bhatt AJ, Gerday E, Talati AJ, Dereddy N, Singh R, Ryan E, Senterre T. Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):314-323. doi: 10.1002/jpn3.70072. Epub 2025 May 25.

Reference Type: DERIVED

PMID: 40415417 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

6344-001A

Identifier Type: -

Identifier Source: org_study_id