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

NCT04555044 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 6344-001A
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 9

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD)

  Up to Day 90

• Alkaline Phosphatase (ALP)

  Up to Day 90

• Aspartate Aminotransferase (AST)

  Up to Day 90

• Alanine Aminotransferase (ALT)

  Up to Day 90

• Gamma-Glutamyl Transferase (GGT)

  Up to Day 90

Study Arms (2)

Clinolipid

EXPERIMENTAL

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.

Drug: Clinolipid

Intralipid

ACTIVE COMPARATOR

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.

Drug: Intralipid

Interventions

Clinolipid DRUG

Lipid injectable emulsion, USP 20%

Clinolipid

Intralipid DRUG

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

Intralipid

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Patient has received a diagnosis of Coronavirus Disease of 2019 (COVID-19) (diagnosis \<2 months prior and/or symptoms have not resolved.
• Newborn patient born to a mother who was diagnosed as COVID-19 positive at delivery or within 2 months prior to delivery
• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (9)

Baxter Investigational Site

Mobile, Alabama, 36604, United States

Location

Baxter Investigational Site

New Haven, Connecticut, 06520, United States

Location

Baxter Investigational Site

Orlando, Florida, 32803, United States

Location

Baxter Investigational Site

Boston, Massachusetts, 09111, United States

Location

Baxter Investigational Site

Jackson, Mississippi, 39216, United States

Location

Baxter Investigational Site

Greenville, North Carolina, 27834, United States

Location

Baxter Investigational Site

Memphis, Tennessee, 38163, United States

Location

Baxter Investigational Site

San Antonio, Texas, 78229, United States

Location

Baxter Investigational Site

Provo, Utah, 84604, United States

Location

Related Publications (1)

• 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.

  PMID: 40415417 DERIVED

MeSH Terms

Conditions

Hyperphagia; Pena Shokeir syndrome, type 1; Short Bowel Syndrome

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Name/Official Title: Baxter Clinical Trials Disclosure Call Center
• Organization: Organization: Baxter Healthcare

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Study Officials

• Baxter Healthcare Corporation

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 18, 2020
• Study Start: January 22, 2021
• Primary Completion: October 16, 2022
• Study Completion: November 16, 2022
• Last Updated: December 27, 2023
• Results First Posted: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)