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Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Sponsored by Fresenius Kabi

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Dec 4, 2025

Phase

Clinical Trial

Sponsor

Fresenius Kabi

Enrollment Target

100

Start Date

Oct 2024

๐Ÿ“Š
1 of 100 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.

Who Can Participate

Inclusion Criteria

Male or female patients, at least 1 month of age. 2. Patients who require PN for at least 5 days/week. 3. Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total energy requirements as PN for at least 56 days. 4. Written informed consent. In case of pediatric patients, informed consent must be obtained from parent(s) or legal representatives. If possible, the assent of the pediatric patient must also be obtained (according to local law).

Exclusion Criteria

Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior to study participation 2. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of SMOFlipid. 3. Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \>250 mg/dL in infants or \>400 mg/

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

100 participants

๐ŸŽ‚

Age Range

1 Month - 17 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Fresenius Kabi

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
NOT_YET_RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Indianapolis

Indiana

Location available
View Indianapolis location page
NOT_YET_RECRUITING

Columbus

Ohio

Location available
View Columbus location page
RECRUITING

Pittsburgh

Pennsylvania

Location available
View Pittsburgh location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Looking for Based on the study title mentioning EFAD (Essential Fatty Acid Deficiency) and PNAC (Parenteral Nutrition Associated Cholestasis), and the use of lipid injectable emulsion, the primary patient-facing condition is: Nutritional Deficiency Treatment in Atlanta?

Join others in Georgia exploring innovative treatment options through clinical research

Based on the study title mentioning EFAD (Essential Fatty Acid Deficiency) and PNAC (Parenteral Nutrition Associated Cholestasis), and the use of lipid injectable emulsion, the primary patient-facing condition is: Nutritional Deficiency Treatment Options in Atlanta, Georgia

If you're searching for Based on the study title mentioning EFAD (Essential Fatty Acid Deficiency) and PNAC (Parenteral Nutrition Associated Cholestasis), and the use of lipid injectable emulsion, the primary patient-facing condition is: Nutritional Deficiency treatment in Atlanta, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Atlanta, Chicago, Indianapolis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Based on the study title mentioning EFAD (Essential Fatty Acid Deficiency) and PNAC (Parenteral Nutrition Associated Cholestasis), and the use of lipid injectable emulsion, the primary patient-facing condition is: Nutritional Deficiency. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Georgia
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Based on the study title mentioning EFAD (Essential Fatty Acid Deficiency) and PNAC (Parenteral Nutrition Associated Cholestasis), and the use of lipid injectable emulsion, the primary patient-facing condition is: Nutritional Deficiency?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Based on the study title mentioning EFAD (Essential Fatty Acid Deficiency) and PNAC (Parenteral Nutrition Associated Cholestasis), and the use of lipid injectable emulsion, the primary patient-facing condition is: Nutritional Deficiency

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Based on the study title mentioning EFAD (Essential Fatty Acid Deficiency) and PNAC (Parenteral Nutrition Associated Cholestasis), and the use of lipid injectable emulsion, the primary patient-facing condition is: Nutritional Deficiency Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06049680. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.