Trial Outcomes & Findings for Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A) (NCT NCT04555044)
NCT ID: NCT04555044
Last Updated: 2023-12-27
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
Up to Day 90
Results posted on
2023-12-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
Baseline characteristics by cohort
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Pre-Term Neonate (<37 weeks)
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Customized
Full Term Neonate (=37 weeks to <1 month)
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
Child (1 to <10 years)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
Adolescent (10 to <18 years)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Weight at birth
Normal (≥ 2500 g)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Weight at birth
Low (1500-2499 g)
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Weight at birth
Very Low (1000-1499 g)
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Weight at birth
Extremely Low (< 1000 g)
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Weight at birth
NA ( Child or Adolescent)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su
Prematurity
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su
Gastroschisis
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 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
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su
Feeding Intolerance
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su
Meconium ileus
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su
Necrotizing enterocolitis
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 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
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 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
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 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
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su
Sepsis
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 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
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 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
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 90Population: 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).
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
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Defined by direct bilirubin ≥2 mg/dL in patients receiving with intravenous lipid emulsion (ILE).
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Plasma liver function test
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Alkaline Phosphatase (ALP)
Screening
|
234.0 IU/L
Standard Deviation 98.24
|
187.6 IU/L
Standard Deviation 71.63
|
|
Alkaline Phosphatase (ALP)
Baseline (Day 1)
|
191.9 IU/L
Standard Deviation 62.43
|
239.7 IU/L
Standard Deviation 112.49
|
|
Alkaline Phosphatase (ALP)
End of Treatment (EOT)
|
405.2 IU/L
Standard Deviation 157.19
|
383.3 IU/L
Standard Deviation 153.87
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Plasma liver function test
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Aspartate Aminotransferase (AST)
Screening
|
44.2 IU/L
Standard Deviation 20.12
|
46.3 IU/L
Standard Deviation 20.76
|
|
Aspartate Aminotransferase (AST)
Baseline (Day 1)
|
45.4 IU/L
Standard Deviation 28.67
|
62.9 IU/L
Standard Deviation 28.00
|
|
Aspartate Aminotransferase (AST)
End of Treatment (EOT)
|
29.0 IU/L
Standard Deviation 12.40
|
37.7 IU/L
Standard Deviation 28.29
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Plasma liver function test
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Alanine Aminotransferase (ALT)
Baseline (Day 1)
|
8.7 IU/L
Standard Deviation 6.88
|
6.7 IU/L
Standard Deviation 0.76
|
|
Alanine Aminotransferase (ALT)
End of treatment (EOT)
|
9.0 IU/L
Standard Deviation 6.48
|
15.3 IU/L
Standard Deviation 26.62
|
|
Alanine Aminotransferase (ALT)
Screening
|
7.2 IU/L
Standard Deviation 2.79
|
10.3 IU/L
Standard Deviation 9.67
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Plasma liver function test
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Gamma-Glutamyl Transferase (GGT)
Screening
|
97.6 IU/L
Standard Deviation 71.82
|
109.5 IU/L
Standard Deviation 71.14
|
|
Gamma-Glutamyl Transferase (GGT)
Baseline (Day 1 )
|
150.1 IU/L
Standard Deviation 76.65
|
120.9 IU/L
Standard Deviation 82.17
|
|
Gamma-Glutamyl Transferase (GGT)
End of Treatment (EOT)
|
109.3 IU/L
Standard Deviation 121.59
|
97.0 IU/L
Standard Deviation 90.39
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Plasma liver function test
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Total Bilirubin
Screening
|
80.065 umol/L
Standard Deviation 36.2491
|
81.133 umol/L
Standard Deviation 51.3912
|
|
Total Bilirubin
Baseline (Day 1)
|
78.678 umol/L
Standard Deviation 34.0366
|
80.877 umol/L
Standard Deviation 26.2704
|
|
Total Bilirubin
End of Treatment (EOT)
|
86.944 umol/L
Standard Deviation 44.6590
|
89.948 umol/L
Standard Deviation 50.0126
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Plasma liver function test
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Direct Bilirubin
Screening
|
0.237 mg/dL
Standard Deviation 0.2086
|
0.266 mg/dL
Standard Deviation 0.1877
|
|
Direct Bilirubin
Baseline (Day 1)
|
0.360 mg/dL
Standard Deviation 0.0699
|
0.357 mg/dL
Standard Deviation 0.0535
|
|
Direct Bilirubin
End of Treatment (EOT)
|
0.390 mg/dL
Standard Deviation 0.3142
|
0.424 mg/dL
Standard Deviation 0.3831
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Phytosterol species
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Stigmasterol Blood Level
Baseline (Day 1)
|
0.80 mg/L
Standard Deviation 1.400
|
1.35 mg/L
Standard Deviation 2.373
|
|
Stigmasterol Blood Level
End of Treatment (EOT)
|
0.69 mg/L
Standard Deviation 0.360
|
3.85 mg/L
Standard Deviation 3.077
|
|
Stigmasterol Blood Level
Maximal Value
|
0.76 mg/L
Standard Deviation 0.542
|
4.07 mg/L
Standard Deviation 3.468
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Phytosterol species
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Campesterol Blood Level
Baseline (Day 1)
|
1.57 mg/dL
Standard Deviation 2.956
|
2.52 mg/dL
Standard Deviation 4.510
|
|
Campesterol Blood Level
End of Treatment (EOT)
|
1.76 mg/dL
Standard Deviation 0.787
|
8.11 mg/dL
Standard Deviation 6.043
|
|
Campesterol Blood Level
Maximal Value
|
1.89 mg/dL
Standard Deviation 1.129
|
8.55 mg/dL
Standard Deviation 6.878
|
SECONDARY outcome
Timeframe: Up to day 90Population: 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.
Phytosterol species.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Sitosterol Blood Level
Baseline (Day 1)
|
4.51 mg/L
Standard Deviation 8.223
|
8.06 mg/L
Standard Deviation 15.782
|
|
Sitosterol Blood Level
End of Treatment (EOT)
|
17.89 mg/L
Standard Deviation 9.499
|
23.40 mg/L
Standard Deviation 17.560
|
|
Sitosterol Blood Level
Maximal Value
|
20.09 mg/L
Standard Deviation 17.225
|
26.05 mg/L
Standard Deviation 22.180
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Cholesterol Blood Level
Baseline (Day 1)
|
2.521 mmol/L
Standard Deviation 0.7933
|
2.537 mmol/L
Standard Deviation 0.9566
|
|
Cholesterol Blood Level
End of Treatment (EOT)
|
3.019 mmol/L
Standard Deviation 0.6337
|
2.773 mmol/L
Standard Deviation 0.6801
|
|
Cholesterol Blood Level
Maximal Value
|
3.194 mmol/L
Standard Deviation 1.2764
|
2.799 mmol/L
Standard Deviation 0.6884
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Squalene Blood Level
Baseline (Day 1)
|
0.28 mg/L
Standard Deviation 0.735
|
0.13 mg/L
Standard Deviation 0.130
|
|
Squalene Blood Level
End of Treatment (EOT)
|
0.50 mg/L
Standard Deviation 0.778
|
0.30 mg/L
Standard Deviation 0.213
|
|
Squalene Blood Level
Maximal Value
|
0.54 mg/L
Standard Deviation 0.777
|
0.30 mg/L
Standard Deviation 0.213
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Calories Nutritional Intake
Parenteral Nutrition(PN), Screening
|
45.1 kCal/kg/24 hours
Standard Deviation 17.19
|
44.1 kCal/kg/24 hours
Standard Deviation 18.41
|
|
Calories Nutritional Intake
PN, Baseline (Day 1)
|
42.3 kCal/kg/24 hours
Standard Deviation 22.29
|
45.4 kCal/kg/24 hours
Standard Deviation 24.42
|
|
Calories Nutritional Intake
PN, Day 2
|
57 kCal/kg/24 hours
Standard Deviation 15.71
|
57.4 kCal/kg/24 hours
Standard Deviation 17.18
|
|
Calories Nutritional Intake
PN, Day 3
|
59.1 kCal/kg/24 hours
Standard Deviation 14.47
|
63.1 kCal/kg/24 hours
Standard Deviation 17.17
|
|
Calories Nutritional Intake
PN, Day 4
|
58.0 kCal/kg/24 hours
Standard Deviation 15.76
|
62.2 kCal/kg/24 hours
Standard Deviation 16.73
|
|
Calories Nutritional Intake
PN, Day 5
|
54.7 kCal/kg/24 hours
Standard Deviation 19.09
|
55.4 kCal/kg/24 hours
Standard Deviation 19.60
|
|
Calories Nutritional Intake
PN, Day 6
|
48.6 kCal/kg/24 hours
Standard Deviation 20.45
|
50.8 kCal/kg/24 hours
Standard Deviation 20.44
|
|
Calories Nutritional Intake
PN, Day 7
|
45.5 kCal/kg/24 hours
Standard Deviation 24.84
|
47.6 kCal/kg/24 hours
Standard Deviation 24.42
|
|
Calories Nutritional Intake
PN, Day 8
|
58.0 kCal/kg/24 hours
Standard Deviation 28.60
|
60.40 kCal/kg/24 hours
Standard Deviation 24.51
|
|
Calories Nutritional Intake
PN, Day 9
|
59.3 kCal/kg/24 hours
Standard Deviation 27.28
|
62.2 kCal/kg/24 hours
Standard Deviation 25.60
|
|
Calories Nutritional Intake
PN, Day 10
|
64.4 kCal/kg/24 hours
Standard Deviation 22.94
|
60.7 kCal/kg/24 hours
Standard Deviation 30.08
|
|
Calories Nutritional Intake
PN, Day 11
|
61.6 kCal/kg/24 hours
Standard Deviation 17.08
|
61.2 kCal/kg/24 hours
Standard Deviation 25.49
|
|
Calories Nutritional Intake
PN, Day 12
|
53.0 kCal/kg/24 hours
Standard Deviation 17.87
|
60.8 kCal/kg/24 hours
Standard Deviation 28.16
|
|
Calories Nutritional Intake
PN, Day 13
|
48.4 kCal/kg/24 hours
Standard Deviation 22.24
|
53.4 kCal/kg/24 hours
Standard Deviation 31.88
|
|
Calories Nutritional Intake
PN, Day 14
|
62.4 kCal/kg/24 hours
Standard Deviation 34.32
|
63.4 kCal/kg/24 hours
Standard Deviation 27.85
|
|
Calories Nutritional Intake
PN, Day 90/EOT
|
34.3 kCal/kg/24 hours
Standard Deviation 15.53
|
42.6 kCal/kg/24 hours
Standard Deviation 23.76
|
|
Calories Nutritional Intake
Enteral Nutrition (EN), Screening
|
14.2 kCal/kg/24 hours
Standard Deviation 14.00
|
8.0 kCal/kg/24 hours
Standard Deviation 5.29
|
|
Calories Nutritional Intake
EN, Baseline Day 1
|
10.6 kCal/kg/24 hours
Standard Deviation 7.82
|
8.8 kCal/kg/24 hours
Standard Deviation 6.25
|
|
Calories Nutritional Intake
EN, Day 2
|
15.4 kCal/kg/24 hours
Standard Deviation 10.57
|
14.6 kCal/kg/24 hours
Standard Deviation 7.74
|
|
Calories Nutritional Intake
EN, Day 3
|
19.8 kCal/kg/24 hours
Standard Deviation 11.99
|
19.6 kCal/kg/24 hours
Standard Deviation 12.54
|
|
Calories Nutritional Intake
EN, Day 4
|
29.2 kCal/kg/24 hours
Standard Deviation 16.78
|
23.8 kCal/kg/24 hours
Standard Deviation 15.96
|
|
Calories Nutritional Intake
EN, Day 5
|
38.9 kCal/kg/24 hours
Standard Deviation 18.50
|
34.3 kCal/kg/24 hours
Standard Deviation 18.14
|
|
Calories Nutritional Intake
EN, Day 6
|
42.9 kCal/kg/24 hours
Standard Deviation 24.24
|
43.2 kCal/kg/24 hours
Standard Deviation 21.34
|
|
Calories Nutritional Intake
EN, Day 7
|
50.8 kCal/kg/24 hours
Standard Deviation 28.40
|
52.3 kCal/kg/24 hours
Standard Deviation 25.06
|
|
Calories Nutritional Intake
EN, Day 8
|
35.5 kCal/kg/24 hours
Standard Deviation 25.63
|
36.4 kCal/kg/24 hours
Standard Deviation 25.84
|
|
Calories Nutritional Intake
EN, Day 9
|
37.6 kCal/kg/24 hours
Standard Deviation 24.47
|
40.9 kCal/kg/24 hours
Standard Deviation 22.83
|
|
Calories Nutritional Intake
EN, Day 10
|
32.0 kCal/kg/24 hours
Standard Deviation 26.29
|
52.2 kCal/kg/24 hours
Standard Deviation 24.35
|
|
Calories Nutritional Intake
EN, Day 11
|
34.4 kCal/kg/24 hours
Standard Deviation 14.73
|
34.3 kCal/kg/24 hours
Standard Deviation 27.46
|
|
Calories Nutritional Intake
EN, Day 12
|
47.2 kCal/kg/24 hours
Standard Deviation 14.67
|
34.6 kCal/kg/24 hours
Standard Deviation 24.06
|
|
Calories Nutritional Intake
EN, Day 90/EOT
|
84.4 kCal/kg/24 hours
Standard Deviation 17.92
|
73.3 kCal/kg/24 hours
Standard Deviation 24.56
|
|
Calories Nutritional Intake
Intravenous (IV) Fluids, Screening
|
20.0 kCal/kg/24 hours
Standard Deviation 10.60
|
22.0 kCal/kg/24 hours
Standard Deviation 10.02
|
|
Calories Nutritional Intake
IV Fluids, Baseline (Day 1)
|
18.3 kCal/kg/24 hours
Standard Deviation 12.74
|
21.0 kCal/kg/24 hours
Standard Deviation 13.21
|
|
Calories Nutritional Intake
IV, Fluids, Day 2
|
16.7 kCal/kg/24 hours
Standard Deviation 12.34
|
33.1 kCal/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
|
Calories Nutritional Intake
IV, Fluids, Day 3
|
—
|
0.5 kCal/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
|
Calories Nutritional Intake
IV, Fluids, Day 5
|
—
|
30.2 kCal/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
|
Calories Nutritional Intake
IV, Fluids, Day 6
|
8.9 kCal/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
—
|
|
Calories Nutritional Intake
IV, Fluids, Day 7
|
—
|
9.3 kCal/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
|
Calories Nutritional Intake
IV, Fluids, Day 90:EOT
|
5.6 kCal/kg/24 hours
Standard Deviation 3.92
|
—
|
|
Calories Nutritional Intake
EN, Day 13
|
50.3 kCal/kg/24 hours
Standard Deviation 24.12
|
33.5 kCal/kg/24 hours
Standard Deviation 23.24
|
|
Calories Nutritional Intake
EN, Day 14
|
30.8 kCal/kg/24 hours
Standard Deviation 36.74
|
35.6 kCal/kg/24 hours
Standard Deviation 26.30
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Protein Nutritional Intake
Parenteral (PN), Screening
|
3.33 g/kg/24hours
Standard Deviation 2.375
|
3.20 g/kg/24hours
Standard Deviation 2.024
|
|
Protein Nutritional Intake
PN, Baseline (Day 1)
|
2.45 g/kg/24hours
Standard Deviation 1.106
|
2.56 g/kg/24hours
Standard Deviation 1.116
|
|
Protein Nutritional Intake
PN, Day 2
|
2.78 g/kg/24hours
Standard Deviation 0.732
|
2.83 g/kg/24hours
Standard Deviation 0.711
|
|
Protein Nutritional Intake
PN, Day 3
|
2.74 g/kg/24hours
Standard Deviation 0.737
|
2.86 g/kg/24hours
Standard Deviation 0.694
|
|
Protein Nutritional Intake
PN, Day 4
|
2.61 g/kg/24hours
Standard Deviation 0.709
|
2.81 g/kg/24hours
Standard Deviation 0.646
|
|
Protein Nutritional Intake
PN, Day 5
|
2.43 g/kg/24hours
Standard Deviation 0.858
|
2.53 g/kg/24hours
Standard Deviation 0.801
|
|
Protein Nutritional Intake
PN, Day 6
|
2.25 g/kg/24hours
Standard Deviation 0.905
|
2.35 g/kg/24hours
Standard Deviation 0.880
|
|
Protein Nutritional Intake
PN, Day 7
|
2.08 g/kg/24hours
Standard Deviation 1.046
|
2.18 g/kg/24hours
Standard Deviation 1.039
|
|
Protein Nutritional Intake
PN, Day 8
|
2.57 g/kg/24hours
Standard Deviation 1.141
|
2.83 g/kg/24hours
Standard Deviation 1.007
|
|
Protein Nutritional Intake
PN, Day 9
|
2.57 g/kg/24hours
Standard Deviation 1.080
|
2.97 g/kg/24hours
Standard Deviation 1.121
|
|
Protein Nutritional Intake
PN, Day 10
|
2.71 g/kg/24hours
Standard Deviation 0.888
|
2.88 g/kg/24hours
Standard Deviation 1.064
|
|
Protein Nutritional Intake
PN, Day 11
|
2.53 g/kg/24hours
Standard Deviation 0.902
|
2.78 g/kg/24hours
Standard Deviation 0.880
|
|
Protein Nutritional Intake
Enteral Nutrition (EN), Screening
|
0.33 g/kg/24hours
Standard Deviation 0.480
|
0.14 g/kg/24hours
Standard Deviation 0.087
|
|
Protein Nutritional Intake
EN, Baseline ( Day 1)
|
0.22 g/kg/24hours
Standard Deviation 0.209
|
0.15 g/kg/24hours
Standard Deviation 0.106
|
|
Protein Nutritional Intake
EN, Day 2
|
0.34 g/kg/24hours
Standard Deviation 0.389
|
0.26 g/kg/24hours
Standard Deviation 0.136
|
|
Protein Nutritional Intake
EN, Day 3
|
0.42 g/kg/24hours
Standard Deviation 0.395
|
0.35 g/kg/24hours
Standard Deviation 0.223
|
|
Protein Nutritional Intake
EN, Day 4
|
0.59 g/kg/24hours
Standard Deviation 0.499
|
0.44 g/kg/24hours
Standard Deviation 0.328
|
|
Protein Nutritional Intake
EN, Day 5
|
0.79 g/kg/24hours
Standard Deviation 0.548
|
0.63 g/kg/24hours
Standard Deviation 0.358
|
|
Protein Nutritional Intake
EN, Day 6
|
0.89 g/kg/24hours
Standard Deviation 0.599
|
0.80 g/kg/24hours
Standard Deviation 0.423
|
|
Protein Nutritional Intake
EN, Day 11
|
0.68 g/kg/24hours
Standard Deviation 0.304
|
0.59 g/kg/24hours
Standard Deviation 0.442
|
|
Protein Nutritional Intake
EN, Day 12
|
0.96 g/kg/24hours
Standard Deviation 0.475
|
0.59 g/kg/24hours
Standard Deviation 0.404
|
|
Protein Nutritional Intake
EN, Day 13
|
1.04 g/kg/24hours
Standard Deviation 0.731
|
0.67 g/kg/24hours
Standard Deviation 0.490
|
|
Protein Nutritional Intake
EN, Day 14
|
0.76 g/kg/24hours
Standard Deviation 0.795
|
0.54 g/kg/24hours
Standard Deviation 0.309
|
|
Protein Nutritional Intake
EN, Day 90/EOT
|
1.69 g/kg/24hours
Standard Deviation 0.659
|
1.34 g/kg/24hours
Standard Deviation 0.427
|
|
Protein Nutritional Intake
PN, Day 12
|
2.31 g/kg/24hours
Standard Deviation 1.039
|
2.75 g/kg/24hours
Standard Deviation 0.969
|
|
Protein Nutritional Intake
PN, Day 13
|
2.16 g/kg/24hours
Standard Deviation 1.163
|
2.43 g/kg/24hours
Standard Deviation 1.240
|
|
Protein Nutritional Intake
PN, Day 14
|
2.37 g/kg/24hours
Standard Deviation 1.315
|
2.76 g/kg/24hours
Standard Deviation 0.969
|
|
Protein Nutritional Intake
PN, Day 90 EOT
|
2.02 g/kg/24hours
Standard Deviation 1.245
|
1.98 g/kg/24hours
Standard Deviation 0.596
|
|
Protein Nutritional Intake
EN, Day 7
|
1.04 g/kg/24hours
Standard Deviation 0.668
|
0.95 g/kg/24hours
Standard Deviation 0.461
|
|
Protein Nutritional Intake
EN, Day 8
|
0.68 g/kg/24hours
Standard Deviation 0.478
|
0.66 g/kg/24hours
Standard Deviation 0.454
|
|
Protein Nutritional Intake
EN, Day 9
|
0.69 g/kg/24hours
Standard Deviation 0.430
|
0.81 g/kg/24hours
Standard Deviation 0.435
|
|
Protein Nutritional Intake
EN, Day 10
|
0.56 g/kg/24hours
Standard Deviation 0.430
|
0.93 g/kg/24hours
Standard Deviation 0.466
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Lipid Nutritional Intake
Parenteral Nutrition (PN), Screening
|
1.56 g/kg/24 hours
Standard Deviation 0.584
|
1.84 g/kg/24 hours
Standard Deviation 0.691
|
|
Lipid Nutritional Intake
PN, Day 2
|
2.48 g/kg/24 hours
Standard Deviation 0.692
|
2.55 g/kg/24 hours
Standard Deviation 0.751
|
|
Lipid Nutritional Intake
PN, Day 3
|
3.07 g/kg/24 hours
Standard Deviation 0.713
|
3.14 g/kg/24 hours
Standard Deviation 0.592
|
|
Lipid Nutritional Intake
PN, Day 4
|
2.96 g/kg/24 hours
Standard Deviation 0.690
|
3.17 g/kg/24 hours
Standard Deviation 0.520
|
|
Lipid Nutritional Intake
PN, Day 5
|
2.78 g/kg/24 hours
Standard Deviation 0.673
|
2.81 g/kg/24 hours
Standard Deviation 0.628
|
|
Lipid Nutritional Intake
PN, Day 6
|
2.38 g/kg/24 hours
Standard Deviation 0.857
|
2.33 g/kg/24 hours
Standard Deviation 0.927
|
|
Lipid Nutritional Intake
PN, Day 7
|
2.15 g/kg/24 hours
Standard Deviation 1.026
|
2.22 g/kg/24 hours
Standard Deviation 1.032
|
|
Lipid Nutritional Intake
PN, Day 10
|
2.73 g/kg/24 hours
Standard Deviation 0.763
|
3.00 g/kg/24 hours
Standard Deviation 0.735
|
|
Lipid Nutritional Intake
PN, Day 11
|
2.97 g/kg/24 hours
Standard Deviation 0.494
|
3.07 g/kg/24 hours
Standard Deviation 0.884
|
|
Lipid Nutritional Intake
PN, Day 12
|
2.78 g/kg/24 hours
Standard Deviation 0.592
|
3.13 g/kg/24 hours
Standard Deviation 0.497
|
|
Lipid Nutritional Intake
PN, Day 13
|
2.70 g/kg/24 hours
Standard Deviation 0.678
|
2.82 g/kg/24 hours
Standard Deviation 0.973
|
|
Lipid Nutritional Intake
PN, Day 14
|
3.30 g/kg/24 hours
Standard Deviation 0.480
|
2.78 g/kg/24 hours
Standard Deviation 0.829
|
|
Lipid Nutritional Intake
PN, Day 90/ EOT
|
1.50 g/kg/24 hours
Standard Deviation 0.863
|
2.27 g/kg/24 hours
Standard Deviation 1.290
|
|
Lipid Nutritional Intake
EN, Baseline (Day 1)
|
0.58 g/kg/24 hours
Standard Deviation 0.459
|
0.46 g/kg/24 hours
Standard Deviation 0.319
|
|
Lipid Nutritional Intake
EN, Day 2
|
0.88 g/kg/24 hours
Standard Deviation 0.741
|
0.77 g/kg/24 hours
Standard Deviation 0.409
|
|
Lipid Nutritional Intake
EN, Day 3
|
1.14 g/kg/24 hours
Standard Deviation 0.844
|
1.04 g/kg/24 hours
Standard Deviation 0.688
|
|
Lipid Nutritional Intake
EN, Day 4
|
1.62 g/kg/24 hours
Standard Deviation 1.073
|
1.27 g/kg/24 hours
Standard Deviation 0.828
|
|
Lipid Nutritional Intake
EN, Day 5
|
2.18 g/kg/24 hours
Standard Deviation 1.168
|
1.81 g/kg/24 hours
Standard Deviation 0.935
|
|
Lipid Nutritional Intake
EN, Day 6
|
2.30 g/kg/24 hours
Standard Deviation 1.279
|
2.21 g/kg/24 hours
Standard Deviation 0.990
|
|
Lipid Nutritional Intake
EN, Day 7
|
2.68 g/kg/24 hours
Standard Deviation 1.436
|
2.66 g/kg/24 hours
Standard Deviation 1.164
|
|
Lipid Nutritional Intake
EN, Day 8
|
1.79 g/kg/24 hours
Standard Deviation 1.190
|
1.88 g/kg/24 hours
Standard Deviation 1.185
|
|
Lipid Nutritional Intake
EN, Day 9
|
1.85 g/kg/24 hours
Standard Deviation 1.142
|
2.17 g/kg/24 hours
Standard Deviation 1.035
|
|
Lipid Nutritional Intake
EN, Day 11
|
1.82 g/kg/24 hours
Standard Deviation 0.802
|
1.73 g/kg/24 hours
Standard Deviation 1.274
|
|
Lipid Nutritional Intake
EN, Day 12
|
2.46 g/kg/24 hours
Standard Deviation 0.833
|
1.74 g/kg/24 hours
Standard Deviation 1.184
|
|
Lipid Nutritional Intake
EN, Day 13
|
2.51 g/kg/24 hours
Standard Deviation 1.149
|
1.89 g/kg/24 hours
Standard Deviation 1.300
|
|
Lipid Nutritional Intake
EN, Day 14
|
1.92 g/kg/24 hours
Standard Deviation 1.809
|
1.61 g/kg/24 hours
Standard Deviation 0.882
|
|
Lipid Nutritional Intake
EN, Day 90 EOT
|
4.33 g/kg/24 hours
Standard Deviation 1.058
|
3.71 g/kg/24 hours
Standard Deviation 1.070
|
|
Lipid Nutritional Intake
PN, Baseline (Day 1)
|
1.74 g/kg/24 hours
Standard Deviation 0.855
|
1.76 g/kg/24 hours
Standard Deviation 0.944
|
|
Lipid Nutritional Intake
PN, Day 8
|
2.92 g/kg/24 hours
Standard Deviation 0.598
|
2.91 g/kg/24 hours
Standard Deviation 0.746
|
|
Lipid Nutritional Intake
PN, Day 9
|
2.64 g/kg/24 hours
Standard Deviation 0.751
|
2.97 g/kg/24 hours
Standard Deviation 0.520
|
|
Lipid Nutritional Intake
Enteral Nutrition (EN), Screening
|
0.71 g/kg/24 hours
Standard Deviation 0.614
|
0.42 g/kg/24 hours
Standard Deviation 0.260
|
|
Lipid Nutritional Intake
EN, Day 10
|
1.59 g/kg/24 hours
Standard Deviation 1.213
|
2.49 g/kg/24 hours
Standard Deviation 1.026
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Carbohydrates Nutritional Intake
Parenteral Nutrition (PN) Screening
|
7.61 g/kg/24 hours
Standard Deviation 2.248
|
7.47 g/kg/24 hours
Standard Deviation 3.087
|
|
Carbohydrates Nutritional Intake
PN, Baseline (Day 1)
|
6.41 g/kg/24 hours
Standard Deviation 3.309
|
6.99 g/kg/24 hours
Standard Deviation 3.710
|
|
Carbohydrates Nutritional Intake
PN, Day 2
|
8.52 g/kg/24 hours
Standard Deviation 2.524
|
8.51 g/kg/24 hours
Standard Deviation 2.894
|
|
Carbohydrates Nutritional Intake
PN, Day 3
|
8.78 g/kg/24 hours
Standard Deviation 2.457
|
9.05 g/kg/24 hours
Standard Deviation 2.950
|
|
Carbohydrates Nutritional Intake
PN, Day 4
|
8.50 g/kg/24 hours
Standard Deviation 2.695
|
9.13 g/kg/24 hours
Standard Deviation 3.025
|
|
Carbohydrates Nutritional Intake
PN, Day 5
|
8.24 g/kg/24 hours
Standard Deviation 3.083
|
8.51 g/kg/24 hours
Standard Deviation 3.216
|
|
Carbohydrates Nutritional Intake
PN, Day 6
|
7.47 g/kg/24 hours
Standard Deviation 3.397
|
8.19 g/kg/24 hours
Standard Deviation 3.265
|
|
Carbohydrates Nutritional Intake
PN, Day 7
|
7.30 g/kg/24 hours
Standard Deviation 3.850
|
7.77 g/kg/24 hours
Standard Deviation 3.746
|
|
Carbohydrates Nutritional Intake
PN, Day 9
|
9.40 g/kg/24 hours
Standard Deviation 4.144
|
9.00 g/kg/24 hours
Standard Deviation 4.700
|
|
Carbohydrates Nutritional Intake
PN, Day 10
|
9.99 g/kg/24 hours
Standard Deviation 3.451
|
9.21 g/kg/24 hours
Standard Deviation 4.840
|
|
Carbohydrates Nutritional Intake
PN, Day 11
|
8.79 g/kg/24 hours
Standard Deviation 2.723
|
9.47 g/kg/24 hours
Standard Deviation 4.123
|
|
Carbohydrates Nutritional Intake
PN, Day 12
|
7.45 g/kg/24 hours
Standard Deviation 2.337
|
9.47 g/kg/24 hours
Standard Deviation 4.697
|
|
Carbohydrates Nutritional Intake
PN, Day 13
|
6.65 g/kg/24 hours
Standard Deviation 3.077
|
8.58 g/kg/24 hours
Standard Deviation 5.046
|
|
Carbohydrates Nutritional Intake
PN, Day 14
|
10.30 g/kg/24 hours
Standard Deviation 5.276
|
10.20 g/kg/24 hours
Standard Deviation 4.836
|
|
Carbohydrates Nutritional Intake
PN, Day 90/EOT
|
6.34 g/kg/24 hours
Standard Deviation 2.535
|
8.10 g/kg/24 hours
Standard Deviation 3.815
|
|
Carbohydrates Nutritional Intake
Enteral Nutrition (EN), Screening
|
1.58 g/kg/24 hours
Standard Deviation 1.657
|
0.86 g/kg/24 hours
Standard Deviation 0.534
|
|
Carbohydrates Nutritional Intake
EN, Baseline (Day 1)
|
1.19 g/kg/24 hours
Standard Deviation 0.893
|
0.95 g/kg/24 hours
Standard Deviation 0.656
|
|
Carbohydrates Nutritional Intake
EN, Day 2
|
1.70 g/kg/24 hours
Standard Deviation 1.195
|
1.59 g/kg/24 hours
Standard Deviation 0.841
|
|
Carbohydrates Nutritional Intake
EN, Day 3
|
2.21 g/kg/24 hours
Standard Deviation 1.362
|
2.14 g/kg/24 hours
Standard Deviation 1.372
|
|
Carbohydrates Nutritional Intake
EN, Day 4
|
3.14 g/kg/24 hours
Standard Deviation 1.765
|
2.64 g/kg/24 hours
Standard Deviation 1.757
|
|
Carbohydrates Nutritional Intake
EN, Day 5
|
4.28 g/kg/24 hours
Standard Deviation 1.968
|
3.75 g/kg/24 hours
Standard Deviation 1.971
|
|
Carbohydrates Nutritional Intake
EN, Day 90/EOT
|
8.77 g/kg/24 hours
Standard Deviation 1.695
|
7.75 g/kg/24 hours
Standard Deviation 2.249
|
|
Carbohydrates Nutritional Intake
Intravenous (IV) Fluids, Screening
|
5.88 g/kg/24 hours
Standard Deviation 3.119
|
6.47 g/kg/24 hours
Standard Deviation 2.947
|
|
Carbohydrates Nutritional Intake
IV Fluids, Baseline (Day 1)
|
5.37 g/kg/24 hours
Standard Deviation 3.748
|
6.19 g/kg/24 hours
Standard Deviation 3.886
|
|
Carbohydrates Nutritional Intake
IV Fluids, Day 2
|
4.92 g/kg/24 hours
Standard Deviation 3.628
|
9.74 g/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
|
Carbohydrates Nutritional Intake
IV Fluids, Day 3
|
—
|
0.14 g/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
|
Carbohydrates Nutritional Intake
IV Fluids, Day 5
|
—
|
8.89 g/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
|
Carbohydrates Nutritional Intake
IV Fluids, Day 6
|
2.62 g/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
—
|
|
Carbohydrates Nutritional Intake
IV Fluids, Day 7
|
—
|
2.72 g/kg/24 hours
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
|
Carbohydrates Nutritional Intake
IV Fluids, Day 90/EOT
|
1.63 g/kg/24 hours
Standard Deviation 1.153
|
—
|
|
Carbohydrates Nutritional Intake
PN, Day 8
|
9.15 g/kg/24 hours
Standard Deviation 4.479
|
8.96 g/kg/24 hours
Standard Deviation 4.260
|
|
Carbohydrates Nutritional Intake
EN, Day 6
|
4.64 g/kg/24 hours
Standard Deviation 2.413
|
4.63 g/kg/24 hours
Standard Deviation 2.123
|
|
Carbohydrates Nutritional Intake
EN, Day 7
|
5.40 g/kg/24 hours
Standard Deviation 2.731
|
5.54 g/kg/24 hours
Standard Deviation 2.463
|
|
Carbohydrates Nutritional Intake
EN, Day 8
|
3.80 g/kg/24 hours
Standard Deviation 2.519
|
3.89 g/kg/24 hours
Standard Deviation 2.500
|
|
Carbohydrates Nutritional Intake
EN, Day 9
|
3.92 g/kg/24 hours
Standard Deviation 2.377
|
4.56 g/kg/24 hours
Standard Deviation 2.217
|
|
Carbohydrates Nutritional Intake
EN, Day 10
|
3.31 g/kg/24 hours
Standard Deviation 2.514
|
5.23 g/kg/24 hours
Standard Deviation 2.247
|
|
Carbohydrates Nutritional Intake
EN, Day 11
|
3.87 g/kg/24 hours
Standard Deviation 1.615
|
3.56 g/kg/24 hours
Standard Deviation 2.635
|
|
Carbohydrates Nutritional Intake
EN, Day 12
|
5.29 g/kg/24 hours
Standard Deviation 1.851
|
3.59 g/kg/24 hours
Standard Deviation 2.443
|
|
Carbohydrates Nutritional Intake
EN, Day 13
|
5.51 g/kg/24 hours
Standard Deviation 2.766
|
3.94 g/kg/24 hours
Standard Deviation 2.733
|
|
Carbohydrates Nutritional Intake
EN, Day 14
|
4.10 g/kg/24 hours
Standard Deviation 3.944
|
3.31 g/kg/24 hours
Standard Deviation 1.827
|
SECONDARY outcome
Timeframe: Up to Day 90Population: 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.
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) = \[Head circumference (mm) on Day X - Head circumference (mm) at baseline\] / \[X/7\]
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
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
|
6.406 mm/week
Standard Deviation 8.6426
|
|
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
|
-0.218 mm/week
Standard Deviation 5.6635
|
SECONDARY outcome
Timeframe: Up to day 90Population: 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.
Change in Weight. from baseline (g/kg/day) to EOT for infants \< 1 year of Age
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=46 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=44 Participants
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
|
|---|---|---|
|
Body Weight
|
7.372 g/kg/day
Standard Deviation 10.1814
|
5.435 g/kg/day
Standard Deviation 11.8946
|
SECONDARY outcome
Timeframe: Upto Day 90Population: 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.
Change in weight from baseline to end of treatment (EOT) for those \> 1 year of age (g/day)
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=1 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=2 Participants
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
|
|---|---|---|
|
Body Weight
|
71.429 g/day
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-100.000 g/day
Standard Deviation 141.4214
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Number of Adverse Events of Special Interest
COAGULATION FACTOR DEFICIENCY
|
0 Number of Events per 100 Patient Days
|
0.2 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
VOMITING
|
0.4 Number of Events per 100 Patient Days
|
0 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
CATHETER SITE ULCER
|
0 Number of Events per 100 Patient Days
|
0.2 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
INFUSION SITE EXTRAVASATION
|
0 Number of Events per 100 Patient Days
|
0.2 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
ACUTE RESPIRATORY FAILURE
|
0.2 Number of Events per 100 Patient Days
|
0 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
BRONCHOPULMONARY DYSPLASIA
|
0.4 Number of Events per 100 Patient Days
|
0.2 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
DYSPNOEA
|
0.2 Number of Events per 100 Patient Days
|
0 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
HYPOXIA
|
0 Number of Events per 100 Patient Days
|
0.2 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
INFANTILE APNOEA
|
0.6 Number of Events per 100 Patient Days
|
0.7 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
NEONATAL RESPIRATORY DISTRESS
|
0 Number of Events per 100 Patient Days
|
0.2 Number of Events per 100 Patient Days
|
|
Number of Adverse Events of Special Interest
STRIDOR
|
0.2 Number of Events per 100 Patient Days
|
0 Number of Events per 100 Patient Days
|
SECONDARY outcome
Timeframe: Up to Day 90Neonatal 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.
Outcome measures
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 Participants
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 Participants
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
|
|---|---|---|
|
Number of Participants With Neonatal Morbidities
Any Neonatal Morbidity
|
13 Participants
|
7 Participants
|
|
Number of Participants With Neonatal Morbidities
Bronchopulmonary dysplasia
|
2 Participants
|
1 Participants
|
|
Number of Participants With Neonatal Morbidities
Retinopathy of prematurity
|
1 Participants
|
0 Participants
|
|
Number of Participants With Neonatal Morbidities
Intraventricular hemorrhage
|
7 Participants
|
6 Participants
|
|
Number of Participants With Neonatal Morbidities
Necrotizing enterocolitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Neonatal Morbidities
Late-onset sepsis
|
2 Participants
|
0 Participants
|
Adverse Events
Clinolipid (Lipid Injectable Emulsion) 20%
Serious events: 2 serious events
Other events: 40 other events
Deaths: 1 deaths
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 participants at risk
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
PNEUMOPERITONEUM
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Nervous system disorders
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE NEONATAL
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
Other adverse events
| Measure |
Clinolipid (Lipid Injectable Emulsion) 20%
n=50 participants at risk
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.
|
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
n=51 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA NEONATAL
|
28.0%
14/50 • Up to day 120
|
29.4%
15/51 • Up to day 120
|
|
Blood and lymphatic system disorders
COAGULATION FACTOR DEFICIENCY
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Cardiac disorders
BRADYCARDIA NEONATAL
|
6.0%
3/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Cardiac disorders
CARDIAC DYSFUNCTION
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Congenital, familial and genetic disorders
ADRENAL INSUFFICIENCY NEONATAL
|
4.0%
2/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Congenital, familial and genetic disorders
ANKYLOGLOSSIA CONGENITAL
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
|
10.0%
5/50 • Up to day 120
|
9.8%
5/51 • Up to day 120
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
4.0%
2/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Congenital, familial and genetic disorders
NEWBORN PERSISTENT PULMONARY HYPERTENSION
|
2.0%
1/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Congenital, familial and genetic disorders
PATENT DUCTUS ARTERIOSUS
|
30.0%
15/50 • Up to day 120
|
15.7%
8/51 • Up to day 120
|
|
Congenital, familial and genetic disorders
PHYTOSTEROLAEMIA
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Congenital, familial and genetic disorders
PSEUDOHYPOALDOSTERONISM
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Endocrine disorders
HYPOTHYROIDISM
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Eye disorders
EYE DISCHARGE
|
2.0%
1/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
2.0%
1/50 • Up to day 120
|
5.9%
3/51 • Up to day 120
|
|
Gastrointestinal disorders
ANAL FISSURE
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
4.0%
2/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
4.0%
2/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Gastrointestinal disorders
INTESTINAL DILATATION
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Gastrointestinal disorders
MECONIUM PLUG SYNDROME
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Gastrointestinal disorders
NECROTISING ENTEROCOLITIS NEONATAL
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
General disorders
ADMINISTRATION SITE EXTRAVASATION
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
General disorders
CATHETER SITE ULCER
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
2.0%
1/50 • Up to day 120
|
7.8%
4/51 • Up to day 120
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/50 • Up to day 120
|
5.9%
3/51 • Up to day 120
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA NEONATAL
|
44.0%
22/50 • Up to day 120
|
39.2%
20/51 • Up to day 120
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Infections and infestations
EYE INFECTION
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Infections and infestations
PUSTULE
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Infections and infestations
SEPSIS NEONATAL
|
10.0%
5/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Infections and infestations
TRACHEITIS
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.0%
3/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Infections and infestations
URINARY TRACT INFECTION FUNGAL
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Infections and infestations
URINARY TRACT INFECTION NEONATAL
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE RESPIRATORY FAILURE
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
0.00%
0/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
10.0%
5/50 • Up to day 120
|
5.9%
3/51 • Up to day 120
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
4.0%
2/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Investigations
CARDIOVASCULAR EXAMINATION ABNORMAL
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Investigations
FREE FATTY ACIDS DECREASED
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Investigations
GASTRIC FLUID ANALYSIS ABNORMAL
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Investigations
PHYTOSTEROL LEVEL INCREASED
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Metabolism and nutrition disorders
FEEDING INTOLERANCE
|
14.0%
7/50 • Up to day 120
|
5.9%
3/51 • Up to day 120
|
|
Metabolism and nutrition disorders
HYPERCHLORAEMIA
|
4.0%
2/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.0%
1/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
2.0%
1/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
4.0%
2/50 • Up to day 120
|
5.9%
3/51 • Up to day 120
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
2.0%
1/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Metabolism and nutrition disorders
NEONATAL HYPONATRAEMIA
|
10.0%
5/50 • Up to day 120
|
13.7%
7/51 • Up to day 120
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
4.0%
2/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF SKIN
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Nervous system disorders
HYDROCEPHALUS
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE
|
0.00%
0/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE NEONATAL
|
12.0%
6/50 • Up to day 120
|
9.8%
5/51 • Up to day 120
|
|
Renal and urinary disorders
RENAL INJURY
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPULMONARY DYSPLASIA
|
4.0%
2/50 • Up to day 120
|
5.9%
3/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
INFANTILE APNOEA
|
10.0%
5/50 • Up to day 120
|
5.9%
3/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL RESPIRATORY DISTRESS
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL RESPIRATORY DISTRESS SYNDROME
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
|
4.0%
2/50 • Up to day 120
|
3.9%
2/51 • Up to day 120
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
2.0%
1/50 • Up to day 120
|
0.00%
0/51 • Up to day 120
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.00%
0/50 • Up to day 120
|
2.0%
1/51 • Up to day 120
|
Additional Information
Name/Official Title: Baxter Clinical Trials Disclosure Call Center
Organization: Baxter Healthcare
Phone: (224) 948-7359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
- Publication restrictions are in place
Restriction type: OTHER