Essential Fatty Acid Deficiency (EFAD)
Conditions
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
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.
Interventions
DRUGClinolipid
Lipid injectable emulsion, USP 20%
DRUGIntralipid
Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 | Up to Day 90 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alkaline Phosphatase (ALP) | Up to Day 90 | Plasma liver function test |
| Aspartate Aminotransferase (AST) | Up to Day 90 | Plasma liver function test |
| Alanine Aminotransferase (ALT) | Up to Day 90 | Plasma liver function test |
| Gamma-Glutamyl Transferase (GGT) | Up to Day 90 | Plasma liver function test |
| Total Bilirubin | Up to Day 90 | Plasma liver function test |
| Direct Bilirubin | Up to Day 90 | Plasma liver function test |
| Stigmasterol Blood Level | Up to Day 90 | Phytosterol species |
| Campesterol Blood Level | Up to Day 90 | Phytosterol species |
| Sitosterol Blood Level | Up to day 90 | Phytosterol species. |
| Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD) | Up to Day 90 | Defined by direct bilirubin ≥2 mg/dL in patients receiving with intravenous lipid emulsion (ILE). |
| Squalene Blood Level | Up to Day 90 | — |
| Calories Nutritional Intake | Up to Day 90 | — |
| Protein Nutritional Intake | Up to Day 90 | — |
| Lipid Nutritional Intake | Up to Day 90 | — |
| Carbohydrates Nutritional Intake | Up to Day 90 | — |
| Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline | Up to Day 90 | 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) = \[Head circumference (mm) on Day X - Head circumference (mm) at baseline\] / \[X/7\] |
| Body Weight | Up to day 90 | Change in Weight. from baseline (g/kg/day) to EOT for infants \< 1 year of Age |
| 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) | — |
| Number of Participants With Neonatal Morbidities | Up to Day 90 | 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. |
| Cholesterol Blood Level | Up to Day 90 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% Clinolipid was 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 was prescribed by the Investigator to provide the daily dosage (based on general pediatric PN guidelines) over 20 to 24 hours and ensure that the maximum lipid infusion rate did not exceed 0.15 g/kg/hour. | 50 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) Intralipid was 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 was prescribed by the Investigator to provide the daily dosage (based on general pediatric PN guidelines) over 20 to 24 hours and ensure that the maximum lipid infusion rate did not exceed 0.15 g/kg/hour. | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Clinolipid (Lipid Injectable Emulsion) 20% | Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 51 Participants | 101 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescent (10 to <18 years) | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized Child (1 to <10 years) | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized Full Term Neonate (=37 weeks to <1 month) | 2 Participants | 2 Participants | 4 Participants |
| Age, Customized Pre-Term Neonate (<37 weeks) | 47 Participants | 47 Participants | 94 Participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Enteropathies including inflammatory gastrointestinal diseases | 0 participants | 1 participants | 1 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Feeding Intolerance | 1 participants | 0 participants | 1 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Gastroschisis | 0 participants | 3 participants | 3 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Meconium ileus | 1 participants | 0 participants | 1 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Necrotizing enterocolitis | 1 participants | 0 participants | 1 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Persistent pulmonary hypertension | 1 participants | 0 participants | 1 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Premature infant with feeding intolerance | 1 participants | 0 participants | 1 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Premature infant with gastroschisis | 0 participants | 1 participants | 2 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Prematurity | 46 participants | 46 participants | 92 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Sepsis | 0 participants | 1 participants | 1 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Short bowel syndrome | 0 participants | 1 participants | 1 participants |
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su Small for gestational age | 0 participants | 1 participants | 1 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 42 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 20 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) White | 19 Participants | 23 Participants | 42 Participants |
| Region of Enrollment United States | 50 participants | 51 participants | 101 participants |
| Sex: Female, Male Female | 16 Participants | 29 Participants | 45 Participants |
| Sex: Female, Male Male | 34 Participants | 22 Participants | 56 Participants |
| Weight at birth Extremely Low (< 1000 g) | 19 Participants | 13 Participants | 32 Participants |
| Weight at birth Low (1500-2499 g) | 4 Participants | 6 Participants | 10 Participants |
| Weight at birth NA ( Child or Adolescent) | 1 Participants | 2 Participants | 3 Participants |
| Weight at birth Normal (≥ 2500 g) | 1 Participants | 2 Participants | 3 Participants |
| Weight at birth Very Low (1000-1499 g) | 25 Participants | 28 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 0 / 51 |
| other Total, other adverse events | 40 / 50 | 39 / 51 |
| serious Total, serious adverse events | 2 / 50 | 2 / 51 |
Outcome results
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
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.~Per protocol set: all patients in the FAS who have Holman Index measurements taken at baseline and at least 1 other timepoint post-baseline, who have received a minimum of 7 days of ILE treatment, and are without a major protocol violation (i.e., violation that potentially impacts the primary endpoint).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 | 0 Participants |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 | 0 Participants |
Secondary
Alanine Aminotransferase (ALT)
Plasma liver function test
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Alanine Aminotransferase (ALT) | Baseline (Day 1) | 8.7 IU/L | Standard Deviation 6.88 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Alanine Aminotransferase (ALT) | Screening | 7.2 IU/L | Standard Deviation 2.79 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Alanine Aminotransferase (ALT) | End of treatment (EOT) | 9.0 IU/L | Standard Deviation 6.48 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Alanine Aminotransferase (ALT) | Baseline (Day 1) | 6.7 IU/L | Standard Deviation 0.76 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Alanine Aminotransferase (ALT) | Screening | 10.3 IU/L | Standard Deviation 9.67 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Alanine Aminotransferase (ALT) | End of treatment (EOT) | 15.3 IU/L | Standard Deviation 26.62 |
Secondary
Alkaline Phosphatase (ALP)
Plasma liver function test
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Alkaline Phosphatase (ALP) | Screening | 234.0 IU/L | Standard Deviation 98.24 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Alkaline Phosphatase (ALP) | Baseline (Day 1) | 191.9 IU/L | Standard Deviation 62.43 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Alkaline Phosphatase (ALP) | End of Treatment (EOT) | 405.2 IU/L | Standard Deviation 157.19 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Alkaline Phosphatase (ALP) | Screening | 187.6 IU/L | Standard Deviation 71.63 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Alkaline Phosphatase (ALP) | Baseline (Day 1) | 239.7 IU/L | Standard Deviation 112.49 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Alkaline Phosphatase (ALP) | End of Treatment (EOT) | 383.3 IU/L | Standard Deviation 153.87 |
Secondary
Aspartate Aminotransferase (AST)
Plasma liver function test
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Aspartate Aminotransferase (AST) | Screening | 44.2 IU/L | Standard Deviation 20.12 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Aspartate Aminotransferase (AST) | Baseline (Day 1) | 45.4 IU/L | Standard Deviation 28.67 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Aspartate Aminotransferase (AST) | End of Treatment (EOT) | 29.0 IU/L | Standard Deviation 12.4 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Aspartate Aminotransferase (AST) | Screening | 46.3 IU/L | Standard Deviation 20.76 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Aspartate Aminotransferase (AST) | Baseline (Day 1) | 62.9 IU/L | Standard Deviation 28 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Aspartate Aminotransferase (AST) | End of Treatment (EOT) | 37.7 IU/L | Standard Deviation 28.29 |
Secondary
Body Weight
Change in weight from baseline to end of treatment (EOT) for those \> 1 year of age (g/day)
Time frame: Upto Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Body Weight | 71.429 g/day | — |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Body Weight | -100.000 g/day | Standard Deviation 141.4214 |
Secondary
Body Weight
Change in Weight. from baseline (g/kg/day) to EOT for infants \< 1 year of Age
Time frame: Up to day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Body Weight | 7.372 g/kg/day | Standard Deviation 10.1814 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Body Weight | 5.435 g/kg/day | Standard Deviation 11.8946 |
Secondary
Calories Nutritional Intake
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 11 | 34.4 kCal/kg/24 hours | Standard Deviation 14.73 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 90/EOT | 34.3 kCal/kg/24 hours | Standard Deviation 15.53 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | Enteral Nutrition (EN), Screening | 14.2 kCal/kg/24 hours | Standard Deviation 14 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Baseline Day 1 | 10.6 kCal/kg/24 hours | Standard Deviation 7.82 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | Parenteral Nutrition(PN), Screening | 45.1 kCal/kg/24 hours | Standard Deviation 17.19 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Baseline (Day 1) | 42.3 kCal/kg/24 hours | Standard Deviation 22.29 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 2 | 57 kCal/kg/24 hours | Standard Deviation 15.71 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 3 | 59.1 kCal/kg/24 hours | Standard Deviation 14.47 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 4 | 58.0 kCal/kg/24 hours | Standard Deviation 15.76 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 5 | 54.7 kCal/kg/24 hours | Standard Deviation 19.09 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 6 | 48.6 kCal/kg/24 hours | Standard Deviation 20.45 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 7 | 45.5 kCal/kg/24 hours | Standard Deviation 24.84 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 8 | 58.0 kCal/kg/24 hours | Standard Deviation 28.6 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 9 | 59.3 kCal/kg/24 hours | Standard Deviation 27.28 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | IV Fluids, Baseline (Day 1) | 18.3 kCal/kg/24 hours | Standard Deviation 12.74 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 10 | 64.4 kCal/kg/24 hours | Standard Deviation 22.94 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 11 | 61.6 kCal/kg/24 hours | Standard Deviation 17.08 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 12 | 53.0 kCal/kg/24 hours | Standard Deviation 17.87 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 13 | 48.4 kCal/kg/24 hours | Standard Deviation 22.24 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | PN, Day 14 | 62.4 kCal/kg/24 hours | Standard Deviation 34.32 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 2 | 15.4 kCal/kg/24 hours | Standard Deviation 10.57 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 3 | 19.8 kCal/kg/24 hours | Standard Deviation 11.99 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 4 | 29.2 kCal/kg/24 hours | Standard Deviation 16.78 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 5 | 38.9 kCal/kg/24 hours | Standard Deviation 18.5 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 6 | 42.9 kCal/kg/24 hours | Standard Deviation 24.24 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 7 | 50.8 kCal/kg/24 hours | Standard Deviation 28.4 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 8 | 35.5 kCal/kg/24 hours | Standard Deviation 25.63 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 9 | 37.6 kCal/kg/24 hours | Standard Deviation 24.47 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 10 | 32.0 kCal/kg/24 hours | Standard Deviation 26.29 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 12 | 47.2 kCal/kg/24 hours | Standard Deviation 14.67 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 13 | 50.3 kCal/kg/24 hours | Standard Deviation 24.12 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 14 | 30.8 kCal/kg/24 hours | Standard Deviation 36.74 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | EN, Day 90/EOT | 84.4 kCal/kg/24 hours | Standard Deviation 17.92 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | Intravenous (IV) Fluids, Screening | 20.0 kCal/kg/24 hours | Standard Deviation 10.6 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | IV, Fluids, Day 2 | 16.7 kCal/kg/24 hours | Standard Deviation 12.34 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | IV, Fluids, Day 6 | 8.9 kCal/kg/24 hours | — |
| Clinolipid (Lipid Injectable Emulsion) 20% | Calories Nutritional Intake | IV, Fluids, Day 90:EOT | 5.6 kCal/kg/24 hours | Standard Deviation 3.92 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 11 | 34.3 kCal/kg/24 hours | Standard Deviation 27.46 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | IV Fluids, Baseline (Day 1) | 21.0 kCal/kg/24 hours | Standard Deviation 13.21 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 2 | 14.6 kCal/kg/24 hours | Standard Deviation 7.74 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 90/EOT | 42.6 kCal/kg/24 hours | Standard Deviation 23.76 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 12 | 34.6 kCal/kg/24 hours | Standard Deviation 24.06 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | Enteral Nutrition (EN), Screening | 8.0 kCal/kg/24 hours | Standard Deviation 5.29 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 3 | 19.6 kCal/kg/24 hours | Standard Deviation 12.54 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Baseline Day 1 | 8.8 kCal/kg/24 hours | Standard Deviation 6.25 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | Intravenous (IV) Fluids, Screening | 22.0 kCal/kg/24 hours | Standard Deviation 10.02 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | IV, Fluids, Day 7 | 9.3 kCal/kg/24 hours | — |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | Parenteral Nutrition(PN), Screening | 44.1 kCal/kg/24 hours | Standard Deviation 18.41 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 4 | 23.8 kCal/kg/24 hours | Standard Deviation 15.96 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Baseline (Day 1) | 45.4 kCal/kg/24 hours | Standard Deviation 24.42 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 13 | 33.5 kCal/kg/24 hours | Standard Deviation 23.24 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 2 | 57.4 kCal/kg/24 hours | Standard Deviation 17.18 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 5 | 34.3 kCal/kg/24 hours | Standard Deviation 18.14 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 3 | 63.1 kCal/kg/24 hours | Standard Deviation 17.17 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | IV, Fluids, Day 2 | 33.1 kCal/kg/24 hours | — |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 4 | 62.2 kCal/kg/24 hours | Standard Deviation 16.73 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 6 | 43.2 kCal/kg/24 hours | Standard Deviation 21.34 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 5 | 55.4 kCal/kg/24 hours | Standard Deviation 19.6 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 14 | 35.6 kCal/kg/24 hours | Standard Deviation 26.3 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 6 | 50.8 kCal/kg/24 hours | Standard Deviation 20.44 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 7 | 52.3 kCal/kg/24 hours | Standard Deviation 25.06 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 7 | 47.6 kCal/kg/24 hours | Standard Deviation 24.42 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | IV, Fluids, Day 3 | 0.5 kCal/kg/24 hours | — |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 8 | 60.40 kCal/kg/24 hours | Standard Deviation 24.51 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 8 | 36.4 kCal/kg/24 hours | Standard Deviation 25.84 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 9 | 62.2 kCal/kg/24 hours | Standard Deviation 25.6 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 90/EOT | 73.3 kCal/kg/24 hours | Standard Deviation 24.56 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 9 | 40.9 kCal/kg/24 hours | Standard Deviation 22.83 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 10 | 60.7 kCal/kg/24 hours | Standard Deviation 30.08 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | IV, Fluids, Day 5 | 30.2 kCal/kg/24 hours | — |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 11 | 61.2 kCal/kg/24 hours | Standard Deviation 25.49 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | EN, Day 10 | 52.2 kCal/kg/24 hours | Standard Deviation 24.35 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 12 | 60.8 kCal/kg/24 hours | Standard Deviation 28.16 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 14 | 63.4 kCal/kg/24 hours | Standard Deviation 27.85 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Calories Nutritional Intake | PN, Day 13 | 53.4 kCal/kg/24 hours | Standard Deviation 31.88 |
Secondary
Campesterol Blood Level
Phytosterol species
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Campesterol Blood Level | Baseline (Day 1) | 1.57 mg/dL | Standard Deviation 2.956 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Campesterol Blood Level | End of Treatment (EOT) | 1.76 mg/dL | Standard Deviation 0.787 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Campesterol Blood Level | Maximal Value | 1.89 mg/dL | Standard Deviation 1.129 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Campesterol Blood Level | Baseline (Day 1) | 2.52 mg/dL | Standard Deviation 4.51 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Campesterol Blood Level | End of Treatment (EOT) | 8.11 mg/dL | Standard Deviation 6.043 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Campesterol Blood Level | Maximal Value | 8.55 mg/dL | Standard Deviation 6.878 |
Secondary
Carbohydrates Nutritional Intake
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 13 | 6.65 g/kg/24 hours | Standard Deviation 3.077 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | Parenteral Nutrition (PN) Screening | 7.61 g/kg/24 hours | Standard Deviation 2.248 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 14 | 10.30 g/kg/24 hours | Standard Deviation 5.276 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | Enteral Nutrition (EN), Screening | 1.58 g/kg/24 hours | Standard Deviation 1.657 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Baseline (Day 1) | 6.41 g/kg/24 hours | Standard Deviation 3.309 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 2 | 1.70 g/kg/24 hours | Standard Deviation 1.195 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 5 | 8.24 g/kg/24 hours | Standard Deviation 3.083 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 3 | 2.21 g/kg/24 hours | Standard Deviation 1.362 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Baseline (Day 1) | 1.19 g/kg/24 hours | Standard Deviation 0.893 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 4 | 3.14 g/kg/24 hours | Standard Deviation 1.765 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 6 | 7.47 g/kg/24 hours | Standard Deviation 3.397 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 5 | 4.28 g/kg/24 hours | Standard Deviation 1.968 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 3 | 8.78 g/kg/24 hours | Standard Deviation 2.457 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 6 | 4.64 g/kg/24 hours | Standard Deviation 2.413 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 7 | 7.30 g/kg/24 hours | Standard Deviation 3.85 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 7 | 5.40 g/kg/24 hours | Standard Deviation 2.731 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 10 | 3.31 g/kg/24 hours | Standard Deviation 2.514 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 8 | 3.80 g/kg/24 hours | Standard Deviation 2.519 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 8 | 9.15 g/kg/24 hours | Standard Deviation 4.479 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 9 | 3.92 g/kg/24 hours | Standard Deviation 2.377 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 12 | 5.29 g/kg/24 hours | Standard Deviation 1.851 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 2 | 8.52 g/kg/24 hours | Standard Deviation 2.524 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 13 | 5.51 g/kg/24 hours | Standard Deviation 2.766 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 9 | 9.40 g/kg/24 hours | Standard Deviation 4.144 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 14 | 4.10 g/kg/24 hours | Standard Deviation 3.944 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 11 | 3.87 g/kg/24 hours | Standard Deviation 1.615 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | EN, Day 90/EOT | 8.77 g/kg/24 hours | Standard Deviation 1.695 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 10 | 9.99 g/kg/24 hours | Standard Deviation 3.451 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | Intravenous (IV) Fluids, Screening | 5.88 g/kg/24 hours | Standard Deviation 3.119 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 90/EOT | 6.34 g/kg/24 hours | Standard Deviation 2.535 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | IV Fluids, Day 2 | 4.92 g/kg/24 hours | Standard Deviation 3.628 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 11 | 8.79 g/kg/24 hours | Standard Deviation 2.723 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | IV Fluids, Baseline (Day 1) | 5.37 g/kg/24 hours | Standard Deviation 3.748 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 12 | 7.45 g/kg/24 hours | Standard Deviation 2.337 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | IV Fluids, Day 6 | 2.62 g/kg/24 hours | — |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | PN, Day 4 | 8.50 g/kg/24 hours | Standard Deviation 2.695 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Carbohydrates Nutritional Intake | IV Fluids, Day 90/EOT | 1.63 g/kg/24 hours | Standard Deviation 1.153 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | IV Fluids, Day 7 | 2.72 g/kg/24 hours | — |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 90/EOT | 7.75 g/kg/24 hours | Standard Deviation 2.249 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 2 | 8.51 g/kg/24 hours | Standard Deviation 2.894 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 3 | 9.05 g/kg/24 hours | Standard Deviation 2.95 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 4 | 9.13 g/kg/24 hours | Standard Deviation 3.025 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 14 | 10.20 g/kg/24 hours | Standard Deviation 4.836 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 90/EOT | 8.10 g/kg/24 hours | Standard Deviation 3.815 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 9 | 4.56 g/kg/24 hours | Standard Deviation 2.217 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 10 | 5.23 g/kg/24 hours | Standard Deviation 2.247 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 11 | 3.56 g/kg/24 hours | Standard Deviation 2.635 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | IV Fluids, Baseline (Day 1) | 6.19 g/kg/24 hours | Standard Deviation 3.886 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | Parenteral Nutrition (PN) Screening | 7.47 g/kg/24 hours | Standard Deviation 3.087 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 5 | 8.51 g/kg/24 hours | Standard Deviation 3.216 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 6 | 8.19 g/kg/24 hours | Standard Deviation 3.265 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 7 | 7.77 g/kg/24 hours | Standard Deviation 3.746 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 8 | 8.96 g/kg/24 hours | Standard Deviation 4.26 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 9 | 9.00 g/kg/24 hours | Standard Deviation 4.7 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 10 | 9.21 g/kg/24 hours | Standard Deviation 4.84 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 11 | 9.47 g/kg/24 hours | Standard Deviation 4.123 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 12 | 9.47 g/kg/24 hours | Standard Deviation 4.697 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Day 13 | 8.58 g/kg/24 hours | Standard Deviation 5.046 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | Enteral Nutrition (EN), Screening | 0.86 g/kg/24 hours | Standard Deviation 0.534 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Baseline (Day 1) | 0.95 g/kg/24 hours | Standard Deviation 0.656 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 2 | 1.59 g/kg/24 hours | Standard Deviation 0.841 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 3 | 2.14 g/kg/24 hours | Standard Deviation 1.372 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 4 | 2.64 g/kg/24 hours | Standard Deviation 1.757 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 5 | 3.75 g/kg/24 hours | Standard Deviation 1.971 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 6 | 4.63 g/kg/24 hours | Standard Deviation 2.123 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 7 | 5.54 g/kg/24 hours | Standard Deviation 2.463 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 8 | 3.89 g/kg/24 hours | Standard Deviation 2.5 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 12 | 3.59 g/kg/24 hours | Standard Deviation 2.443 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 13 | 3.94 g/kg/24 hours | Standard Deviation 2.733 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | EN, Day 14 | 3.31 g/kg/24 hours | Standard Deviation 1.827 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | PN, Baseline (Day 1) | 6.99 g/kg/24 hours | Standard Deviation 3.71 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | Intravenous (IV) Fluids, Screening | 6.47 g/kg/24 hours | Standard Deviation 2.947 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | IV Fluids, Day 2 | 9.74 g/kg/24 hours | — |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | IV Fluids, Day 3 | 0.14 g/kg/24 hours | — |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Carbohydrates Nutritional Intake | IV Fluids, Day 5 | 8.89 g/kg/24 hours | — |
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) = \[Head circumference (mm) on Day X - Head circumference (mm) at baseline\] / \[X/7\]
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline | Change in Length or Height from Baseline to Day 90/EOT | 13.298 mm/week | Standard Deviation 15.4004 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline | Change in Head Circumference from Baseline to Day 90/EOT for Infants < 1 Year of Age | 0.918 mm/week | Standard Deviation 6.5248 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline | Change in Length or Height from Baseline to Day 90/EOT | 6.406 mm/week | Standard Deviation 8.6426 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline | Change in Head Circumference from Baseline to Day 90/EOT for Infants < 1 Year of Age | -0.218 mm/week | Standard Deviation 5.6635 |
Secondary
Cholesterol Blood Level
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Cholesterol Blood Level | Baseline (Day 1) | 2.521 mmol/L | Standard Deviation 0.7933 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Cholesterol Blood Level | End of Treatment (EOT) | 3.019 mmol/L | Standard Deviation 0.6337 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Cholesterol Blood Level | Maximal Value | 3.194 mmol/L | Standard Deviation 1.2764 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Cholesterol Blood Level | Baseline (Day 1) | 2.537 mmol/L | Standard Deviation 0.9566 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Cholesterol Blood Level | End of Treatment (EOT) | 2.773 mmol/L | Standard Deviation 0.6801 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Cholesterol Blood Level | Maximal Value | 2.799 mmol/L | Standard Deviation 0.6884 |
Secondary
Direct Bilirubin
Plasma liver function test
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Direct Bilirubin | Screening | 0.237 mg/dL | Standard Deviation 0.2086 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Direct Bilirubin | Baseline (Day 1) | 0.360 mg/dL | Standard Deviation 0.0699 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Direct Bilirubin | End of Treatment (EOT) | 0.390 mg/dL | Standard Deviation 0.3142 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Direct Bilirubin | Screening | 0.266 mg/dL | Standard Deviation 0.1877 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Direct Bilirubin | Baseline (Day 1) | 0.357 mg/dL | Standard Deviation 0.0535 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Direct Bilirubin | End of Treatment (EOT) | 0.424 mg/dL | Standard Deviation 0.3831 |
Secondary
Gamma-Glutamyl Transferase (GGT)
Plasma liver function test
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Gamma-Glutamyl Transferase (GGT) | Screening | 97.6 IU/L | Standard Deviation 71.82 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Gamma-Glutamyl Transferase (GGT) | Baseline (Day 1 ) | 150.1 IU/L | Standard Deviation 76.65 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Gamma-Glutamyl Transferase (GGT) | End of Treatment (EOT) | 109.3 IU/L | Standard Deviation 121.59 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Gamma-Glutamyl Transferase (GGT) | Screening | 109.5 IU/L | Standard Deviation 71.14 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Gamma-Glutamyl Transferase (GGT) | Baseline (Day 1 ) | 120.9 IU/L | Standard Deviation 82.17 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Gamma-Glutamyl Transferase (GGT) | End of Treatment (EOT) | 97.0 IU/L | Standard Deviation 90.39 |
Secondary
Lipid Nutritional Intake
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Baseline (Day 1) | 1.74 g/kg/24 hours | Standard Deviation 0.855 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | Enteral Nutrition (EN), Screening | 0.71 g/kg/24 hours | Standard Deviation 0.614 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 8 | 2.92 g/kg/24 hours | Standard Deviation 0.598 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Baseline (Day 1) | 0.58 g/kg/24 hours | Standard Deviation 0.459 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 2 | 2.48 g/kg/24 hours | Standard Deviation 0.692 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 2 | 0.88 g/kg/24 hours | Standard Deviation 0.741 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 9 | 2.64 g/kg/24 hours | Standard Deviation 0.751 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 3 | 1.14 g/kg/24 hours | Standard Deviation 0.844 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 4 | 1.62 g/kg/24 hours | Standard Deviation 1.073 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 4 | 2.96 g/kg/24 hours | Standard Deviation 0.69 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 5 | 2.18 g/kg/24 hours | Standard Deviation 1.168 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 10 | 2.73 g/kg/24 hours | Standard Deviation 0.763 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 6 | 2.30 g/kg/24 hours | Standard Deviation 1.279 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 5 | 2.78 g/kg/24 hours | Standard Deviation 0.673 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 7 | 2.68 g/kg/24 hours | Standard Deviation 1.436 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 11 | 2.97 g/kg/24 hours | Standard Deviation 0.494 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 8 | 1.79 g/kg/24 hours | Standard Deviation 1.19 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | Parenteral Nutrition (PN), Screening | 1.56 g/kg/24 hours | Standard Deviation 0.584 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 9 | 1.85 g/kg/24 hours | Standard Deviation 1.142 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 12 | 2.78 g/kg/24 hours | Standard Deviation 0.592 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 10 | 1.59 g/kg/24 hours | Standard Deviation 1.213 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 6 | 2.38 g/kg/24 hours | Standard Deviation 0.857 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 11 | 1.82 g/kg/24 hours | Standard Deviation 0.802 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 13 | 2.70 g/kg/24 hours | Standard Deviation 0.678 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 12 | 2.46 g/kg/24 hours | Standard Deviation 0.833 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 3 | 3.07 g/kg/24 hours | Standard Deviation 0.713 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 13 | 2.51 g/kg/24 hours | Standard Deviation 1.149 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 14 | 3.30 g/kg/24 hours | Standard Deviation 0.48 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 14 | 1.92 g/kg/24 hours | Standard Deviation 1.809 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 7 | 2.15 g/kg/24 hours | Standard Deviation 1.026 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | EN, Day 90 EOT | 4.33 g/kg/24 hours | Standard Deviation 1.058 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Lipid Nutritional Intake | PN, Day 90/ EOT | 1.50 g/kg/24 hours | Standard Deviation 0.863 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 90 EOT | 3.71 g/kg/24 hours | Standard Deviation 1.07 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 2 | 2.55 g/kg/24 hours | Standard Deviation 0.751 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 3 | 3.14 g/kg/24 hours | Standard Deviation 0.592 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | Parenteral Nutrition (PN), Screening | 1.84 g/kg/24 hours | Standard Deviation 0.691 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Baseline (Day 1) | 1.76 g/kg/24 hours | Standard Deviation 0.944 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 4 | 3.17 g/kg/24 hours | Standard Deviation 0.52 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 5 | 2.81 g/kg/24 hours | Standard Deviation 0.628 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 6 | 2.33 g/kg/24 hours | Standard Deviation 0.927 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 7 | 2.22 g/kg/24 hours | Standard Deviation 1.032 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 8 | 2.91 g/kg/24 hours | Standard Deviation 0.746 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 9 | 2.97 g/kg/24 hours | Standard Deviation 0.52 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 10 | 3.00 g/kg/24 hours | Standard Deviation 0.735 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 11 | 3.07 g/kg/24 hours | Standard Deviation 0.884 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 12 | 3.13 g/kg/24 hours | Standard Deviation 0.497 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 13 | 2.82 g/kg/24 hours | Standard Deviation 0.973 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 14 | 2.78 g/kg/24 hours | Standard Deviation 0.829 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | PN, Day 90/ EOT | 2.27 g/kg/24 hours | Standard Deviation 1.29 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | Enteral Nutrition (EN), Screening | 0.42 g/kg/24 hours | Standard Deviation 0.26 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Baseline (Day 1) | 0.46 g/kg/24 hours | Standard Deviation 0.319 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 2 | 0.77 g/kg/24 hours | Standard Deviation 0.409 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 4 | 1.27 g/kg/24 hours | Standard Deviation 0.828 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 5 | 1.81 g/kg/24 hours | Standard Deviation 0.935 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 6 | 2.21 g/kg/24 hours | Standard Deviation 0.99 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 7 | 2.66 g/kg/24 hours | Standard Deviation 1.164 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 8 | 1.88 g/kg/24 hours | Standard Deviation 1.185 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 9 | 2.17 g/kg/24 hours | Standard Deviation 1.035 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 10 | 2.49 g/kg/24 hours | Standard Deviation 1.026 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 11 | 1.73 g/kg/24 hours | Standard Deviation 1.274 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 12 | 1.74 g/kg/24 hours | Standard Deviation 1.184 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 13 | 1.89 g/kg/24 hours | Standard Deviation 1.3 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 14 | 1.61 g/kg/24 hours | Standard Deviation 0.882 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Lipid Nutritional Intake | EN, Day 3 | 1.04 g/kg/24 hours | Standard Deviation 0.688 |
Secondary
Number of Adverse Events of Special Interest
Time frame: Up to Day 120 (30 Days After Subject's Last Study Treatment if hospital discharge has not occurred)
Population: Safety analysis set (SS): the set of all patients who have been administered study treatment (Clinolipid or Intralipid). Patients will be analyzed according to treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | HYPOXIA | 0 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | INFANTILE APNOEA | 0.6 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | NEONATAL RESPIRATORY DISTRESS | 0 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | STRIDOR | 0.2 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | COAGULATION FACTOR DEFICIENCY | 0 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | VOMITING | 0.4 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | CATHETER SITE ULCER | 0 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | INFUSION SITE EXTRAVASATION | 0 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | ACUTE RESPIRATORY FAILURE | 0.2 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | BRONCHOPULMONARY DYSPLASIA | 0.4 Number of Events per 100 Patient Days |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Adverse Events of Special Interest | DYSPNOEA | 0.2 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | DYSPNOEA | 0 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | HYPOXIA | 0.2 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | CATHETER SITE ULCER | 0.2 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | INFANTILE APNOEA | 0.7 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | BRONCHOPULMONARY DYSPLASIA | 0.2 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | NEONATAL RESPIRATORY DISTRESS | 0.2 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | INFUSION SITE EXTRAVASATION | 0.2 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | STRIDOR | 0 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | COAGULATION FACTOR DEFICIENCY | 0.2 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | ACUTE RESPIRATORY FAILURE | 0 Number of Events per 100 Patient Days |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Adverse Events of Special Interest | VOMITING | 0 Number of Events per 100 Patient Days |
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).
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD) | 1 Participants |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD) | 2 Participants |
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.
Time frame: Up to Day 90
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Participants With Neonatal Morbidities | Any Neonatal Morbidity | 13 Participants |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Participants With Neonatal Morbidities | Intraventricular hemorrhage | 7 Participants |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Participants With Neonatal Morbidities | Retinopathy of prematurity | 1 Participants |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Participants With Neonatal Morbidities | Necrotizing enterocolitis | 1 Participants |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Participants With Neonatal Morbidities | Bronchopulmonary dysplasia | 2 Participants |
| Clinolipid (Lipid Injectable Emulsion) 20% | Number of Participants With Neonatal Morbidities | Late-onset sepsis | 2 Participants |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Participants With Neonatal Morbidities | Retinopathy of prematurity | 0 Participants |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Participants With Neonatal Morbidities | Late-onset sepsis | 0 Participants |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Participants With Neonatal Morbidities | Any Neonatal Morbidity | 7 Participants |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Participants With Neonatal Morbidities | Bronchopulmonary dysplasia | 1 Participants |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Participants With Neonatal Morbidities | Intraventricular hemorrhage | 6 Participants |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Number of Participants With Neonatal Morbidities | Necrotizing enterocolitis | 0 Participants |
Secondary
Protein Nutritional Intake
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 3 | 2.74 g/kg/24hours | Standard Deviation 0.737 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 5 | 0.79 g/kg/24hours | Standard Deviation 0.548 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 6 | 0.89 g/kg/24hours | Standard Deviation 0.599 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 10 | 2.71 g/kg/24hours | Standard Deviation 0.888 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 2 | 0.34 g/kg/24hours | Standard Deviation 0.389 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | Parenteral (PN), Screening | 3.33 g/kg/24hours | Standard Deviation 2.375 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Baseline (Day 1) | 2.45 g/kg/24hours | Standard Deviation 1.106 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 2 | 2.78 g/kg/24hours | Standard Deviation 0.732 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 4 | 0.59 g/kg/24hours | Standard Deviation 0.499 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 4 | 2.61 g/kg/24hours | Standard Deviation 0.709 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 5 | 2.43 g/kg/24hours | Standard Deviation 0.858 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 6 | 2.25 g/kg/24hours | Standard Deviation 0.905 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 7 | 2.08 g/kg/24hours | Standard Deviation 1.046 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 8 | 2.57 g/kg/24hours | Standard Deviation 1.141 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 9 | 2.57 g/kg/24hours | Standard Deviation 1.08 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 11 | 2.53 g/kg/24hours | Standard Deviation 0.902 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 12 | 2.31 g/kg/24hours | Standard Deviation 1.039 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 13 | 2.16 g/kg/24hours | Standard Deviation 1.163 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 14 | 2.37 g/kg/24hours | Standard Deviation 1.315 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | PN, Day 90 EOT | 2.02 g/kg/24hours | Standard Deviation 1.245 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | Enteral Nutrition (EN), Screening | 0.33 g/kg/24hours | Standard Deviation 0.48 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Baseline ( Day 1) | 0.22 g/kg/24hours | Standard Deviation 0.209 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 3 | 0.42 g/kg/24hours | Standard Deviation 0.395 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 7 | 1.04 g/kg/24hours | Standard Deviation 0.668 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 8 | 0.68 g/kg/24hours | Standard Deviation 0.478 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 9 | 0.69 g/kg/24hours | Standard Deviation 0.43 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 10 | 0.56 g/kg/24hours | Standard Deviation 0.43 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 11 | 0.68 g/kg/24hours | Standard Deviation 0.304 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 12 | 0.96 g/kg/24hours | Standard Deviation 0.475 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 13 | 1.04 g/kg/24hours | Standard Deviation 0.731 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 14 | 0.76 g/kg/24hours | Standard Deviation 0.795 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Protein Nutritional Intake | EN, Day 90/EOT | 1.69 g/kg/24hours | Standard Deviation 0.659 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 90/EOT | 1.34 g/kg/24hours | Standard Deviation 0.427 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 4 | 0.44 g/kg/24hours | Standard Deviation 0.328 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 12 | 2.75 g/kg/24hours | Standard Deviation 0.969 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 5 | 0.63 g/kg/24hours | Standard Deviation 0.358 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 8 | 0.66 g/kg/24hours | Standard Deviation 0.454 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 6 | 0.80 g/kg/24hours | Standard Deviation 0.423 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 13 | 2.43 g/kg/24hours | Standard Deviation 1.24 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 10 | 2.88 g/kg/24hours | Standard Deviation 1.064 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 12 | 0.59 g/kg/24hours | Standard Deviation 0.404 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 2 | 0.26 g/kg/24hours | Standard Deviation 0.136 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 14 | 2.76 g/kg/24hours | Standard Deviation 0.969 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | Parenteral (PN), Screening | 3.20 g/kg/24hours | Standard Deviation 2.024 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 9 | 0.81 g/kg/24hours | Standard Deviation 0.435 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Baseline (Day 1) | 2.56 g/kg/24hours | Standard Deviation 1.116 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 90 EOT | 1.98 g/kg/24hours | Standard Deviation 0.596 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 2 | 2.83 g/kg/24hours | Standard Deviation 0.711 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 14 | 0.54 g/kg/24hours | Standard Deviation 0.309 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 3 | 2.86 g/kg/24hours | Standard Deviation 0.694 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | Enteral Nutrition (EN), Screening | 0.14 g/kg/24hours | Standard Deviation 0.087 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 4 | 2.81 g/kg/24hours | Standard Deviation 0.646 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 10 | 0.93 g/kg/24hours | Standard Deviation 0.466 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 5 | 2.53 g/kg/24hours | Standard Deviation 0.801 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Baseline ( Day 1) | 0.15 g/kg/24hours | Standard Deviation 0.106 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 6 | 2.35 g/kg/24hours | Standard Deviation 0.88 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 13 | 0.67 g/kg/24hours | Standard Deviation 0.49 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 7 | 2.18 g/kg/24hours | Standard Deviation 1.039 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 3 | 0.35 g/kg/24hours | Standard Deviation 0.223 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 8 | 2.83 g/kg/24hours | Standard Deviation 1.007 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 11 | 0.59 g/kg/24hours | Standard Deviation 0.442 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 9 | 2.97 g/kg/24hours | Standard Deviation 1.121 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | EN, Day 7 | 0.95 g/kg/24hours | Standard Deviation 0.461 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Protein Nutritional Intake | PN, Day 11 | 2.78 g/kg/24hours | Standard Deviation 0.88 |
Secondary
Sitosterol Blood Level
Phytosterol species.
Time frame: Up to day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Sitosterol Blood Level | Baseline (Day 1) | 4.51 mg/L | Standard Deviation 8.223 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Sitosterol Blood Level | End of Treatment (EOT) | 17.89 mg/L | Standard Deviation 9.499 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Sitosterol Blood Level | Maximal Value | 20.09 mg/L | Standard Deviation 17.225 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Sitosterol Blood Level | Baseline (Day 1) | 8.06 mg/L | Standard Deviation 15.782 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Sitosterol Blood Level | End of Treatment (EOT) | 23.40 mg/L | Standard Deviation 17.56 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Sitosterol Blood Level | Maximal Value | 26.05 mg/L | Standard Deviation 22.18 |
Secondary
Squalene Blood Level
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Squalene Blood Level | Baseline (Day 1) | 0.28 mg/L | Standard Deviation 0.735 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Squalene Blood Level | End of Treatment (EOT) | 0.50 mg/L | Standard Deviation 0.778 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Squalene Blood Level | Maximal Value | 0.54 mg/L | Standard Deviation 0.777 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Squalene Blood Level | Baseline (Day 1) | 0.13 mg/L | Standard Deviation 0.13 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Squalene Blood Level | End of Treatment (EOT) | 0.30 mg/L | Standard Deviation 0.213 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Squalene Blood Level | Maximal Value | 0.30 mg/L | Standard Deviation 0.213 |
Secondary
Stigmasterol Blood Level
Phytosterol species
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Stigmasterol Blood Level | Baseline (Day 1) | 0.80 mg/L | Standard Deviation 1.4 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Stigmasterol Blood Level | End of Treatment (EOT) | 0.69 mg/L | Standard Deviation 0.36 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Stigmasterol Blood Level | Maximal Value | 0.76 mg/L | Standard Deviation 0.542 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Stigmasterol Blood Level | Baseline (Day 1) | 1.35 mg/L | Standard Deviation 2.373 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Stigmasterol Blood Level | End of Treatment (EOT) | 3.85 mg/L | Standard Deviation 3.077 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Stigmasterol Blood Level | Maximal Value | 4.07 mg/L | Standard Deviation 3.468 |
Secondary
Total Bilirubin
Plasma liver function test
Time frame: Up to Day 90
Population: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinolipid (Lipid Injectable Emulsion) 20% | Total Bilirubin | Screening | 80.065 umol/L | Standard Deviation 36.2491 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Total Bilirubin | Baseline (Day 1) | 78.678 umol/L | Standard Deviation 34.0366 |
| Clinolipid (Lipid Injectable Emulsion) 20% | Total Bilirubin | End of Treatment (EOT) | 86.944 umol/L | Standard Deviation 44.659 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Total Bilirubin | Screening | 81.133 umol/L | Standard Deviation 51.3912 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Total Bilirubin | Baseline (Day 1) | 80.877 umol/L | Standard Deviation 26.2704 |
| Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Total Bilirubin | End of Treatment (EOT) | 89.948 umol/L | Standard Deviation 50.0126 |