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

Essential Fatty Acid Deficiency (EFAD) Clinical Trial

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 (Part A)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555044
• Other study ID #: 6344-001A
• Status: Completed
• Phase: Phase 4
• Start date: January 22, 2021
• Est. completion date: November 16, 2022

Study information

• Verified date: December 2023
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 16, 2022
• Est. primary completion date: October 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Fatty Acid Deficiency (EFAD)

Intervention

Drug:
• Clinolipid
Lipid injectable emulsion, USP 20%
• Intralipid
Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)

Locations

Country	Name	City	State
United States	Baxter Investigational Site	Boston	Massachusetts
United States	Baxter Investigational Site	Greenville	North Carolina
United States	Baxter Investigational Site	Jackson	Mississippi
United States	Baxter Investigational Site	Memphis	Tennessee
United States	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	Provo	Utah
United States	Baxter Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4	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	Up to Day 90
Secondary	Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD)	Defined by direct bilirubin =2 mg/dL in patients receiving with intravenous lipid emulsion (ILE).	Up to Day 90
Secondary	Alkaline Phosphatase (ALP)	Plasma liver function test	Up to Day 90
Secondary	Aspartate Aminotransferase (AST)	Plasma liver function test	Up to Day 90
Secondary	Alanine Aminotransferase (ALT)	Plasma liver function test	Up to Day 90
Secondary	Gamma-Glutamyl Transferase (GGT)	Plasma liver function test	Up to Day 90
Secondary	Total Bilirubin	Plasma liver function test	Up to Day 90
Secondary	Direct Bilirubin	Plasma liver function test	Up to Day 90
Secondary	Stigmasterol Blood Level	Phytosterol species	Up to Day 90
Secondary	Campesterol Blood Level	Phytosterol species	Up to Day 90
Secondary	Sitosterol Blood Level	Phytosterol species.	Up to day 90
Secondary	Cholesterol Blood Level		Up to Day 90
Secondary	Squalene Blood Level		Up to Day 90
Secondary	Calories Nutritional Intake		Up to Day 90
Secondary	Protein Nutritional Intake		Up to Day 90
Secondary	Lipid Nutritional Intake		Up to Day 90
Secondary	Carbohydrates Nutritional Intake		Up to Day 90
Secondary	Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline	Change in length/height from baseline (mm/week in all) = [Length (mm) on Day X - Length (mm) at baseline] / [X/7] Change in head circumference from baseline (mm/week in infants <1 year) = [Head circumference (mm) on Day X - Head circumference (mm) at baseline] / [X/7]	Up to Day 90
Secondary	Body Weight	Change in Weight. from baseline (g/kg/day) to EOT for infants < 1 year of Age	Up to day 90
Secondary	Body Weight	Change in weight from baseline to end of treatment (EOT) for those > 1 year of age (g/day)	Upto Day 90
Secondary	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)
Secondary	Number of Participants With Neonatal Morbidities	Neonatal Morbidities are presented for premature infants born < 37 weeks of gestation up to 1 month corrected age. Patients may have more than 1 neonatal morbidity.	Up to Day 90