Essential Fatty Acid Deficiency (EFAD)Phase 4NCT02476994
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
A Phase 4 study testing Clinolipid and Intralipid in people with Essential Fatty Acid Deficiency (EFAD), run by Baxter Healthcare Corporation at 4 sites in United States.
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 for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Essential Fatty Acid Deficiency (EFAD)
- What is being tested?
- Clinolipid and Intralipid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2015to Oct 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF
- Patients age <18 years
- Patients who are able to adhere to protocol requirements
- Patients who are expected to require PN for at least 7 days
- Premature infants (<36 weeks of gestation) require at least 80% PN to meet nutrition requirements at study entry; full term infants and children require at least 70% PN to meet nutrition requirements at study entry
Who cannot join
- Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study
- Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
- Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH <7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap >16 mEq/L)
- Patients with hemodynamic instability as judged by the Investigator
- Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
- Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride >400 mg/dL)
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- Patients who are unable to tolerate the necessary laboratory monitoring
- Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment
- Patients who are enrolled in another clinical trial involving an investigational agent
- Patients who were treated with IV lipids within 48 hours of randomization into the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of SC, Neonatology
Charleston, South Carolina, 29425
Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210
Riley Hospital for Children at Indiana Health
Indianapolis, Indiana, 46202
Advocate Children's Hospital
Park Ridge, Illinois, 60068
About this study
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
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.
- Conditions
- Essential Fatty Acid Deficiency (EFAD)
- Being tested
- Clinolipid, Intralipid
- 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
- Medical subject headings
- Hyperphagia, Pena Shokeir syndrome, type 1, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinolipidDrug
IntralipidDrug
Standard-of-Care Soybean Oil-Based Lipid Emulsion
| Study group | Role | What they receive |
|---|---|---|
| Clinolipid (lipid injectable emulsion, USP) 20% | Experimental | Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Receives: Drug: Clinolipid |
| Intralipid 20% (lipid injectable emulsion, USP) | Active comparator | Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Receives: Drug: Intralipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Essential Fatty Acid Deficiency (EFAD)
Holman Index Calculation
Measured: Up to 90 Days
Secondary outcomes (10)
Parenteral Nutrition-Associated Cholestasis (PNAC)
Measured: Up to 90 Days
Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2
Measured: Baseline
Fatty Acid Profile
Measured: Up to 90 Days
Weight
Measured: Up to 90 Days
Phytosterol, Cholesterol, and Squalene Levels
Measured: Up to 90 Days
Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)
Measured: Up to 90 Days
Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake
Measured: Up to 90 Days
Vital Signs
Measured: Up to 90 Days
Adverse Events and Serious Adverse Events
Measured: Up to 30 Days After Subject's Last Study Treatment
Clinical Laboratory Tests
Measured: Up to 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Based on feedback from FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential Fatty Acid Deficiency (EFAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baxter Healthcare Corporation, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476994
- Sponsor's protocol ID
- 6344-001
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2015
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02476994
- Acronym / sponsor ID
- 6344-001
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on feedback from FDA
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Posted 5 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinolipid (lipid injectable emulsion, USP) 20% | Experimental | Drug: ClinolipidDosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. |
| Intralipid 20% (lipid injectable emulsion, USP) | Active comparator | Drug: IntralipidDosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF
- Patients age <18 years
- Patients who are able to adhere to protocol requirements
- Patients who are expected to require PN for at least 7 days
- Premature infants (<36 weeks of gestation) require at least 80% PN to meet nutrition requirements at study entry; full term infants and children require at least 70% PN to meet nutrition requirements at study entry
Key exclusion criteria (10 listed)
- Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study
- Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
- Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH <7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap >16 mEq/L)
- Patients with hemodynamic instability as judged by the Investigator
- Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinolipid | Drug | Clinolipid (lipid injectable emulsion, USP) 20% |
| IntralipidStandard-of-Care Soybean Oil-Based Lipid Emulsion | Drug | Intralipid 20% (lipid injectable emulsion, USP) |
Primary outcome
Essential Fatty Acid Deficiency (EFAD)
Time frame: Up to 90 Days
Holman Index Calculation
10 secondary outcomes
Parenteral Nutrition-Associated Cholestasis (PNAC)
Time frame: Up to 90 Days
Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2
Time frame: Baseline
Fatty Acid Profile
Time frame: Up to 90 Days
Weight
Time frame: Up to 90 Days
Phytosterol, Cholesterol, and Squalene Levels
Time frame: Up to 90 Days
Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)
Time frame: Up to 90 Days
Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake
Time frame: Up to 90 Days
Vital Signs
Time frame: Up to 90 Days
Adverse Events and Serious Adverse Events
Time frame: Up to 30 Days After Subject's Last Study Treatment
Clinical Laboratory Tests
Time frame: Up to 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Essential Fatty Acid Deficiency (EFAD)
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
RecruitingObservational study
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baxter Healthcare Corporation study director
Baxter Healthcare Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clinolipid and Intralipid in people with Essential Fatty Acid Deficiency (EFAD), run by Baxter Healthcare Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Essential Fatty Acid Deficiency (EFAD) (time frame: Up to 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.