Not provided
Not provided
Not provided
Not provided
Not provided
Based on feedback from FDA
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinolipid (lipid injectable emulsion, USP) 20% | Experimental | Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinolipid | Drug |
| ||
| Intralipid |
| Measure | Description | Time Frame |
|---|---|---|
| Essential Fatty Acid Deficiency (EFAD) | Holman Index Calculation | Up to 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Parenteral Nutrition-Associated Cholestasis (PNAC) | Up to 90 Days | |
| Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2 | Baseline | |
| Fatty Acid Profile |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Baxter Healthcare Corporation | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Children's Hospital | Park Ridge | Illinois | 60068 | United States | ||
| Riley Hospital for Children at Indiana Health |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Clinolipid (Lipid Injectable Emulsion, USP) 20% | Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Clinolipid |
| FG001 | Intralipid 20% (Lipid Injectable Emulsion, USP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Standard-of-Care Soybean Oil-Based Lipid Emulsion |
|
| Up to 90 Days |
| Weight | Up to 90 Days |
| Phytosterol, Cholesterol, and Squalene Levels | Up to 90 Days |
| Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin) | Up to 90 Days |
| Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake | Up to 90 Days |
| Vital Signs | Up to 90 Days |
| Adverse Events and Serious Adverse Events | Up to 30 Days After Subject's Last Study Treatment |
| Clinical Laboratory Tests | Up to 90 Days |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Ohio State University, Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Medical University of SC, Neonatology | Charleston | South Carolina | 29425 | United States |
Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.
Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Clinolipid (Lipid Injectable Emulsion, USP) 20% | Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Clinolipid |
| BG001 | Intralipid 20% (Lipid Injectable Emulsion, USP) | Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Essential Fatty Acid Deficiency (EFAD) | Holman Index Calculation | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
| ||||||||||||||||||||||
| Secondary | Parenteral Nutrition-Associated Cholestasis (PNAC) | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
| |||||||||||||||||||||||
| Secondary | Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2 | Due to early termination of the study, no formal analysis was conducted. | Posted | Baseline |
|
| |||||||||||||||||||||||
| Secondary | Fatty Acid Profile | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
| |||||||||||||||||||||||
| Secondary | Weight | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
| |||||||||||||||||||||||
| Secondary | Phytosterol, Cholesterol, and Squalene Levels | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
| |||||||||||||||||||||||
| Secondary | Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin) | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
| |||||||||||||||||||||||
| Secondary | Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
| |||||||||||||||||||||||
| Secondary | Vital Signs | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
| |||||||||||||||||||||||
| Secondary | Adverse Events and Serious Adverse Events | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 30 Days After Subject's Last Study Treatment |
|
| |||||||||||||||||||||||
| Secondary | Clinical Laboratory Tests | Due to early termination of the study, no formal analysis was conducted. | Posted | Up to 90 Days |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinolipid (Lipid Injectable Emulsion, USP) 20% | Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Clinolipid | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | Intralipid 20% (Lipid Injectable Emulsion, USP) | Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Disclosure Group | Baxter Healthcare | joe_archer@baxter.com |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| C536647 | Pena Shokeir syndrome, type 1 |
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|