Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Conditions
Keywords
Parenteral nutrition, Neonates, Infants, Lipid emulsions, Intravenous
Brief summary
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
Interventions
DRUGSmoflipid 20% (investigational lipid for parenteral nutrition)
Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.
DRUGIntralipid® 20%
Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.
Sponsors
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
* Neonates and infants, expected to require parenteral nutrition (PN) for 28 days * Postmenstrual age ≥ 24 weeks * Birth weight ≥ 750g * Gastroschisis, duodenal, jejunal or ileal atresia, volvulus, spontaneous intestinal perforation or necrotizing enterocolitis (Bell's stage 2B or higher) * At least 80% of nutritional needs at baseline received by PN * Signed and dated informed consent obtained from at least one parent or legal guardian
Exclusion criteria
* Conjugated bilirubin \> 0.6 mg/dL * Any known pre-, intra- or posthepatic complication increasing conjugated bilirubin levels \> 0.6, mg/dL during study participation * Suspected liver disease or liver damage based on either aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) exceeding 2.5x upper limit of normal range * Active bloodstream infection demonstrated by positive blood culture at screening * Cystic fibrosis * Meconium ileus * Serum triglyceride levels \> 250 mg/dL * Cyanotic congenital heart defect * Severe renal failure with serum creatinine \> 2.0 mg/dL * History of shock requiring vasopressors * Anasarca * Extracorporeal Membrane Oxygenation (ECMO) * Known inborn errors of metabolism * Known congenital viral infection * Unlikely to survive longer than 28 days * Known hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample | Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl | Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Length (Change From Baseline) | Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up | Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007). |
| Head Circumference (Change From Baseline) | Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up | Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007). |
| Time to Full Enteral or Oral Feeds | Day 29/end of treatment, if continued: Day 85/end of treatment | Time to full enteral or oral feeds (i.e. PN weaning) is the time from the randomization date to the date of the first full enteral or oral Feeds. |
| Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment | RBC refers to red blood cells. Timepoints \>10% of Subjects (overall) are displayed. |
| Length of Stay in Hospital | Day 1- Follow up (7 days after end of treatment) | Length of stay in hospital (time from randomization to discharge) was be calculated. NA=Not available |
| Ratio of Independent Bloodstream Infections to Number of Days on Study Medication | Day 1-29 or -85 if continued + Follow-up | The Ratio is the incidence of bloodstream infection by numbers of day on study medication. |
| Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication | Day 1-29 or -85 if continued + Follow-up | — |
| Body Weight (Change From Baseline) | Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up) | Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007). |
| Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels | Day 1-29 or -85 if continued + Follow-up | — |
| Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study | Day 1-29 or -85 if continued + Follow-up | The area under the curve (AUC\>1.5) is defined as the area between conjugated bilirubin concentrations \> 1.5 mg/dL and the horizontal line at 1.5 mg/dL, restricted by the time point of study withdrawal, if applicable. Analysis displays the summary of Area Under the Curve of Bilirubin Levels for the Time Period in Which Conjugated are \>1.5 mg/dL |
| Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization | Day 1-29 or -85 if continued + Follow-up | The Analysis was performed over the entire study period. |
| Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First) | Day 1-29 or -85 if continued + Follow-up | — |
| Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment | — |
| Holman Index | Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment | Essential fatty acid deficiency is based on the ratio of Mead acid and Arachidonic acid (also called the triene/tetraene ratio or Holman index; Holman, 1960). A ratio of \> 0.2 was considered abnormal (=essential fatty acid deficiency; Holman et al., 1979). Timepoints with \>10% of patients are displayed. |
| Number of Patients Who Complete PN Treatment Without Lipid Minimization | Day 1-29 or -85 if continued + Follow-up | The Analysis was conducted over all study phases. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intralipid® 20% Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein. | 78 |
| Smoflipid 20% Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions.
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein. | 83 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Any other reason not specified | 0 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Weaned off earlier than 28 days | 44 | 43 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
| Overall Study | Withdrawal due to increased conjugated bilirubin | 1 | 0 |
Baseline characteristics
| Characteristic | Intralipid® 20% | Total | Smoflipid 20% |
|---|---|---|---|
| Age, Continuous | 8.3 days STANDARD_DEVIATION 12.16 | 9.9 days STANDARD_DEVIATION 17.67 | 11.4 days STANDARD_DEVIATION 21.58 |
| Age, Customized Age category Infant (>=28 days) | 3 Participants | 9 Participants | 6 Participants |
| Age, Customized Age category Newborn (0-27 days) | 75 Participants | 152 Participants | 77 Participants |
| Body length | 44.36 cm STANDARD_DEVIATION 4.407 | 44.77 cm STANDARD_DEVIATION 4.739 | 45.15 cm STANDARD_DEVIATION 5.024 |
| Body length (category for age) High | 0 Participants | 0 Participants | 0 Participants |
| Body length (category for age) Low | 12 Participants | 37 Participants | 25 Participants |
| Body length (category for age) Normal | 60 Participants | 113 Participants | 53 Participants |
| Body length Z-score | -1.02 units on a scale STANDARD_DEVIATION 1.124 | -1.11 units on a scale STANDARD_DEVIATION 1.24 | -1.21 units on a scale STANDARD_DEVIATION 1.339 |
| Body weight | 2.25 kg STANDARD_DEVIATION 0.663 | 2.35 kg STANDARD_DEVIATION 0.783 | 2.44 kg STANDARD_DEVIATION 0.871 |
| Body weight (category for age) High | 0 Participants | 0 Participants | 0 Participants |
| Body weight (category for age) Low | 12 Participants | 32 Participants | 20 Participants |
| Body weight (category for age) Normal | 62 Participants | 124 Participants | 62 Participants |
| Body weight Z-score | -0.90 units on a scale STANDARD_DEVIATION 0.969 | -0.98 units on a scale STANDARD_DEVIATION 1.034 | -1.06 units on a scale STANDARD_DEVIATION 1.09 |
| Duration of pretreatment | 8.8 days STANDARD_DEVIATION 8.25 | 8.0 days STANDARD_DEVIATION 7.86 | 7.3 days STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 25 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 136 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Head circumference | 31.28 cm STANDARD_DEVIATION 2.798 | 31.49 cm STANDARD_DEVIATION 3.024 | 31.69 cm STANDARD_DEVIATION 3.225 |
| Head circumference (category for age) High | 2 Participants | 3 Participants | 1 Participants |
| Head circumference (category for age) Low | 9 Participants | 29 Participants | 20 Participants |
| Head circumference (category for age) Normal | 62 Participants | 119 Participants | 57 Participants |
| Head circumference Z-score | -0.76 units on a scale STANDARD_DEVIATION 1.184 | -0.87 units on a scale STANDARD_DEVIATION 1.218 | -0.97 units on a scale STANDARD_DEVIATION 1.249 |
| Postmenstrual age at birth | 238.4 days STANDARD_DEVIATION 23.98 | 240.9 days STANDARD_DEVIATION 24.18 | 243.2 days STANDARD_DEVIATION 24.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 15 Participants | 4 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 | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 16 Participants | 10 Participants |
| Race (NIH/OMB) White | 57 Participants | 122 Participants | 65 Participants |
| Sex: Female, Male Female | 45 Participants | 84 Participants | 39 Participants |
| Sex: Female, Male Male | 33 Participants | 77 Participants | 44 Participants |
| Underlying disease type NEC | 6 Participants | 15 Participants | 9 Participants |
| Underlying disease type No NEC | 72 Participants | 146 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 78 | 1 / 83 |
| other Total, other adverse events | 55 / 78 | 59 / 83 |
| serious Total, serious adverse events | 5 / 78 | 8 / 83 |
Outcome results
Primary
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample
Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.
Time frame: Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl
Population: The numbers in the subgroups refer to 100%
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intralipid® 20% | The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample | Combined | 3 Participants |
| Intralipid® 20% | The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample | NEC | 0 Participants |
| Intralipid® 20% | The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample | No NEC | 3 Participants |
| Smoflipid 20% | The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample | No NEC | 1 Participants |
| Smoflipid 20% | The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample | Combined | 2 Participants |
| Smoflipid 20% | The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample | NEC | 1 Participants |
Secondary
Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study
The area under the curve (AUC\>1.5) is defined as the area between conjugated bilirubin concentrations \> 1.5 mg/dL and the horizontal line at 1.5 mg/dL, restricted by the time point of study withdrawal, if applicable. Analysis displays the summary of Area Under the Curve of Bilirubin Levels for the Time Period in Which Conjugated are \>1.5 mg/dL
Time frame: Day 1-29 or -85 if continued + Follow-up
Population: Missing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intralipid® 20% | Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study | Initial Treatment Phase | 0.587 mg/dl*days | Standard Deviation 2.662 |
| Intralipid® 20% | Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study | Extended Treatment Phase | 11.609 mg/dl*days | Standard Deviation 15.184 |
| Smoflipid 20% | Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study | Initial Treatment Phase | 0.804 mg/dl*days | Standard Deviation 3.47 |
| Smoflipid 20% | Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study | Extended Treatment Phase | 0.900 mg/dl*days | Standard Deviation 2.013 |
Secondary
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Time frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
Population: Over time analysis of laboratory parameters were assessed at all timepoints as available. Timepoints \>10% of Subjects (overall) are displayed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | b-sitosterol Change to EoT | 39.854 ug/mL | Standard Deviation 38.5996 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Ergosterol Change to EoT extension | 0.002 ug/mL | Standard Deviation 0.0038 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Stigmasterol Change to EoT | 4.830 ug/mL | Standard Deviation 5.6464 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lathosterol Baseline | 2.411 ug/mL | Standard Deviation 0.9417 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Campesterol Baseline | 12.396 ug/mL | Standard Deviation 10.199 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lathosterol Change to EoT | -0.366 ug/mL | Standard Deviation 1.1811 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Stigmasterol Change to EoT extension | 17.862 ug/mL | Standard Deviation 3.0202 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lathosterol Change to EoT extension | -0.801 ug/mL | Standard Deviation 0.8797 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Beta(b-) sitosterol Baseline | 45.076 ug/mL | Standard Deviation 28.852 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lanosterol Baseline | 1.281 ug/mL | Standard Deviation 0.8046 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Sitostanol Baseline | 0.838 ug/mL | Standard Deviation 0.5692 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lanosterol Change to EoT | 0.273 ug/mL | Standard Deviation 1.0466 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Campesterol Change to EoT | 15.385 ug/mL | Standard Deviation 21.4772 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lanosterol Change to EoT extension | 1.039 ug/mL | Standard Deviation 0.9342 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Sitostanol Change to EoT | 0.945 ug/mL | Standard Deviation 0.9989 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Desmosterol Baseline | 1.396 ug/mL | Standard Deviation 1.18371 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | b-sitosterol Change to EoT extension | 129.938 ug/mL | Standard Deviation 52.8942 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Desmosterol Change to EoT | -0.508 ug/mL | Standard Deviation 2.0678 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Sitostanol Change to Eot extension | 0.134 ug/mL | Standard Deviation 0.0931 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Desmosterol Change to EoT extension | -2.337 ug/mL | Standard Deviation 4.289 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Campesterol Change to EoT extension | 56.681 ug/mL | Standard Deviation 34.4784 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Cholesterol Baseline | 1159.638 ug/mL | Standard Deviation 293.2282 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Ergosterol Baseline | 0.028 ug/mL | Standard Deviation 0.021 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Cholesterol Change to EoT | -129.433 ug/mL | Standard Deviation 295.6223 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Stigmasterol Baseline | 7.649 ug/mL | Standard Deviation 4.0597 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Cholesterol Change to EoT extension | 145.100 ug/mL | Standard Deviation 243.1133 |
| Intralipid® 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Ergosterol Change to EoT | -0.007 ug/mL | Standard Deviation 0.0183 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Cholesterol Change to EoT extension | -232.250 ug/mL | Standard Deviation 621.2414 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Beta(b-) sitosterol Baseline | 41.900 ug/mL | Standard Deviation 28.7879 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | b-sitosterol Change to EoT | -6.357 ug/mL | Standard Deviation 22.4175 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | b-sitosterol Change to EoT extension | -14.247 ug/mL | Standard Deviation 46.0845 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Campesterol Baseline | 11.628 ug/mL | Standard Deviation 10.4005 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Campesterol Change to EoT | -3.079 ug/mL | Standard Deviation 9.6125 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Stigmasterol Baseline | 6.473 ug/mL | Standard Deviation 3.5595 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Stigmasterol Change to EoT | -2.658 ug/mL | Standard Deviation 3.2875 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Stigmasterol Change to EoT extension | -2.422 ug/mL | Standard Deviation 5.1974 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Sitostanol Baseline | 0.710 ug/mL | Standard Deviation 0.4423 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Sitostanol Change to EoT | -0.238 ug/mL | Standard Deviation 0.4344 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Sitostanol Change to Eot extension | -0.169 ug/mL | Standard Deviation 0.2486 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Ergosterol Baseline | 0.025 ug/mL | Standard Deviation 0.0215 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Ergosterol Change to EoT | 0.001 ug/mL | Standard Deviation 0.0214 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Ergosterol Change to EoT extension | -0.010 ug/mL | Standard Deviation 0.0267 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lathosterol Baseline | 2.215 ug/mL | Standard Deviation 1.0751 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lathosterol Change to EoT | -0.279 ug/mL | Standard Deviation 1.1651 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lathosterol Change to EoT extension | -0.956 ug/mL | Standard Deviation 2.2253 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lanosterol Baseline | 1.135 ug/mL | Standard Deviation 0.563 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lanosterol Change to EoT | -0.385 ug/mL | Standard Deviation 0.5471 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Lanosterol Change to EoT extension | -0.548 ug/mL | Standard Deviation 0.7836 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Desmosterol Baseline | 1.196 ug/mL | Standard Deviation 1.0923 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Desmosterol Change to EoT | -0.014 ug/mL | Standard Deviation 1.3948 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Desmosterol Change to EoT extension | -0.562 ug/mL | Standard Deviation 1.6695 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Cholesterol Baseline | 1163.654 ug/mL | Standard Deviation 334.7942 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Cholesterol Change to EoT | -23.072 ug/mL | Standard Deviation 358.8932 |
| Smoflipid 20% | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Campesterol Change to EoT extension | -8.159 ug/mL | Standard Deviation 22.0449 |
Secondary
Body Length (Change From Baseline)
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Time frame: Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up
Population: The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intralipid® 20% | Body Length (Change From Baseline) | Day 36 | Low | 7 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 15 | Normal | 47 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 36 | Normal | 14 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Baseline | Low | 12 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 36 | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 15 | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 43 | Low | 4 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 8 | Normal | 59 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 43 | Normal | 13 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 22 | Low | 10 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 43 | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Baseline | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 50 | Low | 5 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 22 | Normal | 31 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 50 | Normal | 10 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 8 | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 50 | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 22 | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 57 | Low | 1 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Baseline | Normal | 60 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 57 | Normal | 9 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 29 | Low | 6 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 57 | High | 1 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 29 | Normal | 27 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Follow up | Low | 16 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 15 | Low | 14 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Follow up | Normal | 40 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 29 | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Follow up | High | 0 Participants |
| Intralipid® 20% | Body Length (Change From Baseline) | Day 8 | Low | 14 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Follow up | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Baseline | Low | 25 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Baseline | Normal | 53 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Baseline | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 8 | Low | 30 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 8 | Normal | 49 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 8 | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 15 | Low | 25 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 15 | Normal | 39 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 15 | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 22 | Low | 17 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 22 | Normal | 29 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 22 | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 29 | Normal | 20 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 29 | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 36 | Low | 6 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 36 | Normal | 10 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 36 | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 43 | Low | 4 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 43 | Normal | 9 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 43 | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 50 | Low | 2 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 50 | Normal | 8 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 50 | High | 0 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 57 | Low | 1 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 57 | Normal | 6 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 57 | High | 1 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Follow up | Low | 26 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Follow up | Normal | 27 Participants |
| Smoflipid 20% | Body Length (Change From Baseline) | Day 29 | Low | 13 Participants |
Secondary
Body Weight (Change From Baseline)
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Time frame: Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up)
Population: The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intralipid® 20% | Body Weight (Change From Baseline) | Baseline | Low | 12 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 36 | High | 1 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 15 | High | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 43 | Low | 2 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 8 | Normal | 61 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 43 | Normal | 15 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 22 | Low | 8 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 43 | High | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Baseline | High | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 50 | Low | 2 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 22 | Normal | 31 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 50 | Normal | 10 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 8 | High | 1 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 50 | High | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 22 | High | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 57 | Low | 1 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Baseline | Normal | 62 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 57 | Normal | 10 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 29 | Normal | 25 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 57 | High | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 15 | Low | 13 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 64 | Low | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 29 | High | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 64 | Normal | 9 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 8 | Low | 14 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 64 | High | 0 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 36 | Low | 4 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Follow-up | Low | 16 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 15 | Normal | 45 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Follow-up | Normal | 43 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 36 | Normal | 16 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Follow-up | High | 1 Participants |
| Intralipid® 20% | Body Weight (Change From Baseline) | Day 29 | Low | 6 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Follow-up | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 29 | Low | 9 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Baseline | Low | 20 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Baseline | Normal | 62 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Baseline | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 8 | Low | 22 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 8 | Normal | 55 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 8 | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 15 | Low | 16 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 15 | Normal | 48 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 15 | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 22 | Low | 14 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 22 | Normal | 31 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 22 | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 29 | Normal | 24 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 29 | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 36 | Low | 5 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 36 | Normal | 13 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 36 | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 43 | Low | 3 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 43 | Normal | 8 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 43 | High | 1 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 50 | Low | 3 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 50 | Normal | 7 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 50 | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 57 | Low | 1 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 57 | Normal | 7 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 57 | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 64 | Low | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 64 | Normal | 6 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Day 64 | High | 0 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Follow-up | Low | 15 Participants |
| Smoflipid 20% | Body Weight (Change From Baseline) | Follow-up | Normal | 40 Participants |
Secondary
Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization
The Analysis was performed over the entire study period.
Time frame: Day 1-29 or -85 if continued + Follow-up
Population: Missing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid® 20% | Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization | 27.8 Cumulative days | Standard Deviation 21.98 |
| Smoflipid 20% | Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization | 26.7 Cumulative days | Standard Deviation 19.94 |
Secondary
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC refers to red blood cells. Timepoints \>10% of Subjects (overall) are displayed.
Time frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
Population: Over time analysis of laboratory parameters were assessed at all timepoints as available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Mead acid Change to EoT | -4.19 ug/mL | Standard Deviation 3.315 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Eicosapentaenoic acid Baseline | 7.36 ug/mL | Standard Deviation 6.545 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Eicosapentaenoic acid Change to EoT | -1.57 ug/mL | Standard Deviation 7.336 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Eicosapentaenoic acid Change to EoT extension phase | 1.96 ug/mL | Standard Deviation 10.389 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Docosahexaenoic acid Baseline | 41.14 ug/mL | Standard Deviation 14.724 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Docosahexaenoic Acid Change to Eot | -1.36 ug/mL | Standard Deviation 17.721 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Docosahexaenoic Acid Change to EoT extension | 9.55 ug/mL | Standard Deviation 19.462 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Arachidonic Acid Baseline | 148.80 ug/mL | Standard Deviation 52.531 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Arachidonic Acid Change to EoT | -25.36 ug/mL | Standard Deviation 59.925 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Arachidonic Acid Change to EoT extension | -8.18 ug/mL | Standard Deviation 51.138 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Alpha-linolenic Acid Baseline | 19.24 ug/mL | Standard Deviation 12.675 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Alpha-linolenic Acid Change to EoT | -2.01 ug/mL | Standard Deviation 17.452 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Alpha-linolenic Acid Change to EoT extension | 5.88 ug/mL | Standard Deviation 19.477 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Linoleic acid Baseline | 460.62 ug/mL | Standard Deviation 211.354 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Linoleic acid Change to EoT | 50.95 ug/mL | Standard Deviation 270.029 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Linoleic acid Change to EoT extension | 209.99 ug/mL | Standard Deviation 286.361 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Mead acid Baseline | 4.42 ug/mL | Standard Deviation 5.888 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Mead acid Change to EoT | -2.46 ug/mL | Standard Deviation 6.816 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Mead Acid Change to EoT extension | 1.82 ug/mL | Standard Deviation 9.045 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Eicosapentaenoic acid Baseline | 4.20 ug/mL | Standard Deviation 2.533 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Eicosapentaenoic acid Change to EoT | 0.56 ug/mL | Standard Deviation 2.375 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Eicosapentaenoic acid Change to EoT extension | 2.05 ug/mL | Standard Deviation 2.841 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Docosahexaenoic acid Baseline | 94.18 ug/mL | Standard Deviation 26.246 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Docosahexaenoic acid Change to EoT | -41.60 ug/mL | Standard Deviation 53.983 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Docosahexaenoic acid Change to EoT extension | -15.81 ug/mL | Standard Deviation 22.577 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Arachidonic acid Baseline | 281.53 ug/mL | Standard Deviation 63.839 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Arachidonic acid Change to EoT | -41.60 ug/mL | Standard Deviation 53.983 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Arachidonic acid Change to EoT extension | -47.30 ug/mL | Standard Deviation 62.47 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Alpha-linolenic acid Baseline | 2.31 ug/mL | Standard Deviation 1.014 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Alpha-linolenic acid Change to EoT | 0.52 ug/mL | Standard Deviation 1.312 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Alpha-linolenic acid Change to EoT extension | 1.37 ug/mL | Standard Deviation 0.587 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Linoleic acid Baseline | 140.45 ug/mL | Standard Deviation 57.461 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Linoleic acid Change to EoT | 57.04 ug/mL | Standard Deviation 64.201 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Linoleic acid Change to EoT extension | 86.36 ug/mL | Standard Deviation 77.716 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Mead acid Baseline | 9.21 ug/mL | Standard Deviation 4.378 |
| Intralipid® 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Mead acid Change to EoT extension | -7.45 ug/mL | Standard Deviation 4.576 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Mead Acid Change to EoT extension | -6.94 ug/mL | Standard Deviation 17.595 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Linoleic acid Change to EoT | 4.29 ug/mL | Standard Deviation 42.276 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Eicosapentaenoic acid Baseline | 14.52 ug/mL | Standard Deviation 16.48 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Eicosapentaenoic acid Baseline | 5.21 ug/mL | Standard Deviation 3.954 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Eicosapentaenoic acid Change to EoT | 30.44 ug/mL | Standard Deviation 38.615 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Alpha-linolenic acid Baseline | 2.12 ug/mL | Standard Deviation 1.06 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Eicosapentaenoic acid Change to EoT extension phase | 40.62 ug/mL | Standard Deviation 51.417 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Eicosapentaenoic acid Change to EoT | 19.22 ug/mL | Standard Deviation 11.433 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Docosahexaenoic acid Baseline | 47.31 ug/mL | Standard Deviation 18.484 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Mead acid Change to EoT | -3.50 ug/mL | Standard Deviation 2.872 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Docosahexaenoic Acid Change to Eot | 40.06 ug/mL | Standard Deviation 28.678 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Eicosapentaenoic acid Change to EoT extension | 31.83 ug/mL | Standard Deviation 11.973 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Docosahexaenoic Acid Change to EoT extension | 49.93 ug/mL | Standard Deviation 41.868 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Alpha-linolenic acid Change to EoT | -0.04 ug/mL | Standard Deviation 1.049 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Arachidonic Acid Baseline | 149.42 ug/mL | Standard Deviation 47.438 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Docosahexaenoic acid Baseline | 92.53 ug/mL | Standard Deviation 28.435 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Arachidonic Acid Change to EoT | -31.47 ug/mL | Standard Deviation 54.249 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Linoleic acid Change to EoT extension | 0.06 ug/mL | Standard Deviation 68.506 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Arachidonic Acid Change to EoT extension | -60.00 ug/mL | Standard Deviation 73.737 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Docosahexaenoic acid Change to EoT | -40.92 ug/mL | Standard Deviation 60.93 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Alpha-linolenic Acid Baseline | 16.57 ug/mL | Standard Deviation 13.081 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Alpha-linolenic acid Change to EoT extension | -0.17 ug/mL | Standard Deviation 1.365 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Alpha-linolenic Acid Change to EoT | -3.31 ug/mL | Standard Deviation 13.25 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Docosahexaenoic acid Change to EoT extension | 34.85 ug/mL | Standard Deviation 17.145 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Alpha-linolenic Acid Change to EoT extension | -0.55 ug/mL | Standard Deviation 11.454 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Mead acid Change to EoT extension | -5.40 ug/mL | Standard Deviation 3.777 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Linoleic acid Baseline | 427.44 ug/mL | Standard Deviation 185.206 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Arachidonic acid Baseline | 268.99 ug/mL | Standard Deviation 71.369 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Linoleic acid Change to EoT | -41.68 ug/mL | Standard Deviation 190.749 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Linoleic acid Baseline | 130.67 ug/mL | Standard Deviation 53.022 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Linoleic acid Change to EoT extension | -50.25 ug/mL | Standard Deviation 2011.292 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Arachidonic acid Change to EoT | -40.92 ug/mL | Standard Deviation 60.93 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Mead acid Baseline | 4.35 ug/mL | Standard Deviation 7.62 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Mead acid Baseline | 8.30 ug/mL | Standard Deviation 4.289 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Mead acid Change to EoT | -2.19 ug/mL | Standard Deviation 8.011 |
| Smoflipid 20% | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | RBC Arachidonic acid Change to EoT extension | -66.75 ug/mL | Standard Deviation 47.096 |
Secondary
Head Circumference (Change From Baseline)
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Time frame: Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up
Population: The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 57 | Low | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Baseline | Low | 9 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Baseline | Normal | 62 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Baseline | High | 2 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 8 | Low | 10 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 8 | Normal | 63 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 8 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 15 | Low | 7 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 15 | Normal | 54 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 15 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 22 | Low | 5 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 22 | Normal | 36 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 22 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 29 | Low | 3 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 29 | Normal | 30 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 29 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 36 | Low | 2 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 36 | Normal | 18 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 36 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 43 | Low | 1 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 43 | Normal | 16 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 43 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 50 | Low | 1 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 50 | Normal | 14 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 50 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Follow up | Normal | 46 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 57 | Normal | 9 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 57 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 64 | Low | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 64 | Normal | 8 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Day 64 | High | 0 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Follow up | Low | 9 Participants |
| Intralipid® 20% | Head Circumference (Change From Baseline) | Follow up | High | 0 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 57 | Low | 0 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 36 | Normal | 10 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Baseline | Low | 20 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Follow up | Normal | 39 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Baseline | Normal | 57 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 36 | High | 1 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Baseline | High | 1 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 57 | Normal | 6 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 8 | Low | 21 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 43 | Low | 2 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 8 | Normal | 59 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 64 | High | 0 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 8 | High | 1 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 43 | Normal | 11 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 15 | Low | 13 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 57 | High | 1 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 15 | Normal | 51 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 43 | High | 0 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 15 | High | 1 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Follow up | High | 3 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 22 | Low | 12 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 50 | Low | 1 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 22 | Normal | 34 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 64 | Low | 0 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 22 | High | 0 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 50 | Normal | 8 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 29 | Low | 8 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Follow up | Low | 9 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 29 | Normal | 25 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 50 | High | 1 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 29 | High | 0 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 64 | Normal | 5 Participants |
| Smoflipid 20% | Head Circumference (Change From Baseline) | Day 36 | Low | 5 Participants |
Secondary
Holman Index
Essential fatty acid deficiency is based on the ratio of Mead acid and Arachidonic acid (also called the triene/tetraene ratio or Holman index; Holman, 1960). A ratio of \> 0.2 was considered abnormal (=essential fatty acid deficiency; Holman et al., 1979). Timepoints with \>10% of patients are displayed.
Time frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intralipid® 20% | Holman Index | Baseline | >=0.20 <0.40 | 0 Participants |
| Intralipid® 20% | Holman Index | EoT initial Treatment phase | <0.05 | 62 Participants |
| Intralipid® 20% | Holman Index | Day 29 | <0.05 | 27 Participants |
| Intralipid® 20% | Holman Index | EoT initial Treatment phase | >=0.05 <0.20 | 2 Participants |
| Intralipid® 20% | Holman Index | Baseline | >=0.05 <0.20 | 9 Participants |
| Intralipid® 20% | Holman Index | EoT initial Treatment phase | >=0.20 <0.40 | 0 Participants |
| Intralipid® 20% | Holman Index | Day 29 | >=0.05 <0.20 | 1 Participants |
| Intralipid® 20% | Holman Index | EoT initial Treatment phase | >=0.40 | 0 Participants |
| Intralipid® 20% | Holman Index | Baseline | >=0.40 | 0 Participants |
| Intralipid® 20% | Holman Index | Day 29 | >=0.20 <0.40 | 0 Participants |
| Intralipid® 20% | Holman Index | EoT Extension phase | <0.05 | 10 Participants |
| Intralipid® 20% | Holman Index | EoT initial Treatment phase | Not assessed | 14 Participants |
| Intralipid® 20% | Holman Index | EoT Extension phase | >=0.05 <0.20 | 1 Participants |
| Intralipid® 20% | Holman Index | Day 29 | >=0.40 | 0 Participants |
| Intralipid® 20% | Holman Index | EoT Extension phase | >=0.20 <0.40 | 0 Participants |
| Intralipid® 20% | Holman Index | Baseline | Not assessed | 8 Participants |
| Intralipid® 20% | Holman Index | EoT Extension phase | >=0.40 | 0 Participants |
| Intralipid® 20% | Holman Index | Day 29 | Not assessed | 50 Participants |
| Intralipid® 20% | Holman Index | EoT Extension phase | Not assessed | 67 Participants |
| Intralipid® 20% | Holman Index | Baseline | <0.05 | 61 Participants |
| Smoflipid 20% | Holman Index | EoT Extension phase | Not assessed | 71 Participants |
| Smoflipid 20% | Holman Index | Baseline | <0.05 | 72 Participants |
| Smoflipid 20% | Holman Index | Baseline | >=0.05 <0.20 | 5 Participants |
| Smoflipid 20% | Holman Index | Baseline | >=0.20 <0.40 | 1 Participants |
| Smoflipid 20% | Holman Index | Baseline | >=0.40 | 0 Participants |
| Smoflipid 20% | Holman Index | Baseline | Not assessed | 5 Participants |
| Smoflipid 20% | Holman Index | Day 29 | <0.05 | 27 Participants |
| Smoflipid 20% | Holman Index | Day 29 | >=0.05 <0.20 | 1 Participants |
| Smoflipid 20% | Holman Index | Day 29 | >=0.20 <0.40 | 0 Participants |
| Smoflipid 20% | Holman Index | Day 29 | >=0.40 | 0 Participants |
| Smoflipid 20% | Holman Index | Day 29 | Not assessed | 55 Participants |
| Smoflipid 20% | Holman Index | EoT initial Treatment phase | <0.05 | 69 Participants |
| Smoflipid 20% | Holman Index | EoT initial Treatment phase | >=0.05 <0.20 | 2 Participants |
| Smoflipid 20% | Holman Index | EoT initial Treatment phase | >=0.20 <0.40 | 0 Participants |
| Smoflipid 20% | Holman Index | EoT initial Treatment phase | >=0.40 | 0 Participants |
| Smoflipid 20% | Holman Index | EoT initial Treatment phase | Not assessed | 12 Participants |
| Smoflipid 20% | Holman Index | EoT Extension phase | <0.05 | 11 Participants |
| Smoflipid 20% | Holman Index | EoT Extension phase | >=0.05 <0.20 | 1 Participants |
| Smoflipid 20% | Holman Index | EoT Extension phase | >=0.20 <0.40 | 0 Participants |
| Smoflipid 20% | Holman Index | EoT Extension phase | >=0.40 | 0 Participants |
Secondary
Length of Stay in Hospital
Length of stay in hospital (time from randomization to discharge) was be calculated. NA=Not available
Time frame: Day 1- Follow up (7 days after end of treatment)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intralipid® 20% | Length of Stay in Hospital | 65.0 Median time (days) until discharge |
| Smoflipid 20% | Length of Stay in Hospital | 50.5 Median time (days) until discharge |
Secondary
Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels
Time frame: Day 1-29 or -85 if continued + Follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intralipid® 20% | Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels | Initial Treatment Phase | 0 Participants |
| Intralipid® 20% | Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels | Extension Phase | 0 Participants |
| Smoflipid 20% | Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels | Initial Treatment Phase | 1 Participants |
| Smoflipid 20% | Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels | Extension Phase | 0 Participants |
Secondary
Number of Patients Who Complete PN Treatment Without Lipid Minimization
The Analysis was conducted over all study phases.
Time frame: Day 1-29 or -85 if continued + Follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intralipid® 20% | Number of Patients Who Complete PN Treatment Without Lipid Minimization | 73 Participants |
| Smoflipid 20% | Number of Patients Who Complete PN Treatment Without Lipid Minimization | 79 Participants |
Secondary
Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication
Time frame: Day 1-29 or -85 if continued + Follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intralipid® 20% | Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication | 5 Participants |
| Smoflipid 20% | Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication | 6 Participants |
Secondary
Ratio of Independent Bloodstream Infections to Number of Days on Study Medication
The Ratio is the incidence of bloodstream infection by numbers of day on study medication.
Time frame: Day 1-29 or -85 if continued + Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid® 20% | Ratio of Independent Bloodstream Infections to Number of Days on Study Medication | 0.002 ratio | Standard Deviation 0.0105 |
| Smoflipid 20% | Ratio of Independent Bloodstream Infections to Number of Days on Study Medication | 0.003 ratio | Standard Deviation 0.0123 |
Secondary
Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First)
Time frame: Day 1-29 or -85 if continued + Follow-up
Population: NA=Not available Since the number of events was not sufficient, no further analysis was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intralipid® 20% | Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First) | NA Number of days |
| Smoflipid 20% | Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First) | NA Number of days |
Secondary
Time to Full Enteral or Oral Feeds
Time to full enteral or oral feeds (i.e. PN weaning) is the time from the randomization date to the date of the first full enteral or oral Feeds.
Time frame: Day 29/end of treatment, if continued: Day 85/end of treatment
Population: The Standard Deviation for Time to Event was not calculated. NA=Not available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intralipid® 20% | Time to Full Enteral or Oral Feeds | 21.95 Time to event in days |
| Smoflipid 20% | Time to Full Enteral or Oral Feeds | 23.29 Time to event in days |