A Phase 3 interventional study of Smoflipid 20% Lipid Emulsion for Injection and Intralipid, 20% Intravenous Emulsion in Cholestasis of Parenteral Nutrition, sponsored by Indiana University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Indiana University · Phase 3, Interventional, and Prevention
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.
Intestinal failure associated liver disease (IFALD) is a cholestatic liver disease associated with prolonged need for parenteral nutrition. This disease can lead to such serious complications as liver failure and need for transplantation. In the neonatal population, short bowel syndrome, due to intestinal resection, is the most common cause of intestinal failure. While the exact cause is yet to be determined, it is felt the lipid component of parenteral nutrition is a large contributor to the development of this disease. Currently, there is no standard preventative strategy to attempt to decrease the risk of IFALD in the high risk, post-surgical neonatal population. The investigators aim to complete a randomized trial comparing two possible preventative strategies. One group will receive a composite lipid containing fish oil (Smoflipid) and the other group will receive soy-based lipid at reduced dosing.
150 studies on the registry are indexed under Cholestasis; 18 are open to participants now.
This study's enrollment of 24 is below the median of 53 across 90 interventional studies indexed under Cholestasis.
Browse Cholestasis studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Neonates with anticipated need for parenteral nutrition (based on primary physicians opinion) for greater than or equal to four weeks and one of the following diagnoses:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this arm will receive the composite fish oil lipid, Smoflipid, at standard dosing up to 3 g/kg/day. Patients will be started on a dose of 1 g/kg/day and titrated up to maximum dose. As enteral nutrition is advanced the lipid dose will be weaned per study protocol and dietary recommendations.
Drug: Smoflipid 20% Lipid Emulsion for Injection
Patients randomized to this arm will receive soy-based lipid (Intralipid) at a dose of 1 g/kg/day throughout their enrollment in the study.
Drug: Intralipid, 20% Intravenous Emulsion
Patients who retrospectively received soy-based lipid (Intralipid) at standard dosing of 2-3 g/kg/day were eligible for inclusion. Patients in this group were matched to prospective patients based on diagnosis, gestational age, and length of lipid therapy.
Drug: Intralipid, 20% Intravenous Emulsion
Intravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day
Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day
Also known as: Intralipid 20% Reduction
Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day
Also known as: Intralipid 20% Historic
Number of Participants With Cholestasis
Cholestasis was defined as a direct bilirubin \> 2 mg/dL on two measurements 5 to 7 days apart.
Time frame: Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.
Weight Velocity
Weight velocity was calculated as the difference in weight from end to start of study divided by number of days enrolled in study.
Time frame: Patient weight was recorded at enrollment, weekly during time enrolled, and at end of study for up to a maximum of 12 weeks. End and enrollment weights were used to calculate velocity.
Length Velocity
Length velocity was defined as the difference in length from end of study compared to enrollment divided by the number of days enrolled in study.
Time frame: Length was measured at enrollment, weekly during time enrolled in study, and end of study up to a maximum of 12 weeks. End and enrollment measurements were used for velocity.
Head Circumference (OFC) Velocity
OFC velocity was calculated as difference end and start of study divided by number of days enrolled in study.
Time frame: OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity.
Average Total Calorie Intake
Total calorie intake, including parenteral and enteral sources, were averaged on a weekly basis.
Time frame: Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.
Number of Patients With Enteral Autonomy at End of Study
Percentage of patients with enteral autonomy at time of leaving or stopping study was calculated. Enteral autonomy was defined as relying on enteral nutrition only for nutrition intake with no need for parenteral nutrition supplementation.
Time frame: Enteral autonomy was recorded at the study end point for each individual patient. This end point was at time of stopping study lipid, discharge from hospital, or maximum of 12 weeks.
Number of Patients With Essential Fatty Acid Deficiency (EFAD)
Essential fatty acid deficiency was defined as a triene to tetraene ratio greater than 0.05.
Time frame: Essential fatty acid levels were measured every 4 weeks during enrollment for a maximum of up to 12 weeks.
AST Change Over Time
The change of AST over time was calculated and compared between groups. AST change was calculated as AST end - AST enrollment.
Time frame: AST was recorded at enrollment and every 2 weeks while enrolled in the study up to a maximum of 12 weeks.
ALT Change Over Time
The rate of change of ALT over time was compared between groups using mixed model analysis. Change of ALT was calculated as ALT at end of study compared to ALT at enrollment.
Time frame: ALT measured at enrollment and every 2 weeks for max 12 weeks.
Alkaline Phosphatase Change Over Time
Alkaline phosphatase was recorded at enrollment and every 2 weeks. The change in alkaline phosphatase was calculated as alkaline phosphatase at end minus enrollment.
Time frame: Alkaline phosphatase was measured at enrollment and every 2 weeks for max of 12 weeks.
Triglyceride Level Over Time
All enrolled patients had serum triglyceride levels monitored at enrollment and weekly. The triglyceride level changes was calculated using values at the end of study compared to enrollment with mean and standard deviation calculated for each treatment group.
Time frame: Serum triglyceride levels monitored at enrollment and weekly during time enrolled in study for a maximum of 12 weeks.
Gamma Glutamyl Transferase (GGT) Over Time
GGT was documented at baseline and regularly intervals with level compared over time between groups. GGT was compared by treatment group for levels at end of study and enrollment.
Time frame: GGT was measured at enrollment and every 2 weeks while enrolled in the study for a maximum of up to 12 weeks.
Number of Patients With Retinopathy of Prematurity
The rate of retinopathy of prematurity (ROP) was compared between groups. ROP was diagnosed based on ophthalmologist examination with all stages included.
Time frame: Diagnosis was based on diagnosis during time of initial hospitalization to level 4 NICU.
Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease
The rate of BPD was documented and compared between groups. BPD was diagnosed based on need for respiratory support at 28 days of age. All levels of severity were included.
Time frame: All patient had diagnosis of BPD documented from admission at level 4 NICU.
NICU Length of Stay
The length of stay at the level 4 NICU was compared between groups.
Time frame: Length of stay will be calculated based on documenting each patient's admission date and date leaving the NICU.
Three Year Development- Communication
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes. Scores are separated into on schedule, monitoring zone, and below cutoff. These thresholds vary by aged screened. Possible screens used for this age group include 36 months, 42 months, and 48 months dependent on exact chronologic age screen completed. At 36 months communication 45-60 is on schedule; 35-40 monitoring, and \<35 below cutoff. For 42 months on schedule 40-60; monitoring 30-35; below cutoff \<35. For 48 months on schedule 45-60; monitoring 35-40; below cutoff \<35.
Time frame: ASQ was completed during the third year of life from 3 years 0 days to 3 years 364 days of chronologic age.
Three Year Development: Gross Motor
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcome, there are three possible scoring categories on schedule (normal), monitoring zone, below cutoff. Score thresholds by possible screens include: 36 months on schedule 50-60; monitoring 40-45; below cutoff \<40. 42 months on schedule 50-60; monitoring 40-45; below cutoff \<40. 48 months on schedule 45-60; monitoring 35-40; below cutoff \<35.
Time frame: three year chronological age 3 years and 0 days to 3 years and 364 days
Three Year Development: Fine Motor
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes with three scoring categories: on schedule (normal), monitoring zone, and below cutoff. These thresholds vary by each category and screening age. Based on the possible screens for chronological age the score categories are: 36 months: 35-60 on schedule; 20-30 monitoring; \<20 below cutoff. 42 months: 35-60 on schedule; 20-30 monitoring; \<20 below cutoff. 48 months: 35-60 on schedule; 20-30 monitoring; \<20 below cutoff.
Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
Three Year Development: Problem Solving
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three possible score categories: on schedule (normal), monitoring zone, and below cutoff. Category thresholds vary by outcome category and age of screen. There are three possible screens that were used for this population, chosen based on chronologic age. The score categories based on age are: 36 months: 45-60 on schedule; 35-40 monitoring; \<35 below cutoff. 42 months: 40-60 on schdule; 30-35 monitoring; \<30 below cutoff. 48 months: 45-60 on schedule; 35-40 monitoring; \<35 below cutoff
Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
Three Year Development: Personal Social
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three score categories possible including on schedule (normal), monitoring zone, and below cutoff. These thresholds vary based on outcome measure and age of screen completed. Screen used depends on chronological age at screen. Score thresholds for each age include: 36 months: 45-60 on schedule; 35-40 monitoring; \<35 below cutoff. 42 months: 45-60 on schedule; 35-40 monitoring; \<35 below cutoff. 48 months: 40-60 on schedule; 30-40 monitoring; \<30 below cutoff.
Time frame: three year chronological age (3 years and 0 days to 3 years and 364 days)
Patients were eligible for enrollment if they were admitted to the level IV NICU, required abdominal surgery, and needed TPN. Patients were excluded if they had signs of liver disease at baseline. Informed consent was obtained, and once screening lab work completed patients were randomized into one of two prospective treatment groups. Historic controls were included from previous two years prior to enrollment with selection based on same eligibility criteria.
| Milestone | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Started | 12 | 12 | 24 |
| Completed | 12 | 12 | 24 |
| Not completed | 0 | 0 | 0 |
Cholestasis was defined as a direct bilirubin \> 2 mg/dL on two measurements 5 to 7 days apart.
| Participants | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Number of Participants With Cholestasis | 1 | 3 | 7 |
Weight velocity was calculated as the difference in weight from end to start of study divided by number of days enrolled in study.
| grams per day | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Weight Velocity | 28.6 ± 10.6 | 23.0 ± 11.9 | 24.6 ± 8.2 |
Length velocity was defined as the difference in length from end of study compared to enrollment divided by the number of days enrolled in study.
| centimeters per day | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Length Velocity | 0.13 ± 0.08 | 0.09 ± 0.65 | 0.10 ± 0.08 |
OFC velocity was calculated as difference end and start of study divided by number of days enrolled in study.
| centimeters per day | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Head Circumference (OFC) Velocity | 0.09 ± 0.03 | 0.07 ± 0.06 | 0.10 ± 0.05 |
Total calorie intake, including parenteral and enteral sources, were averaged on a weekly basis.
| kcal per kilograms per day | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Average Total Calorie Intake | 114.0 ± 9.1 | 101.9 ± 10.5 | 109.1 ± 8.3 |
Percentage of patients with enteral autonomy at time of leaving or stopping study was calculated. Enteral autonomy was defined as relying on enteral nutrition only for nutrition intake with no need for parenteral nutrition supplementation.
| Participants | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Number of Patients With Enteral Autonomy at End of Study | 9 | 10 | 23 |
Essential fatty acid deficiency was defined as a triene to tetraene ratio greater than 0.05.
| Participants | Smoflipid 20% | Intralipid 20% Reduction |
|---|---|---|
| Number of Patients With Essential Fatty Acid Deficiency (EFAD) | 0 | 1 |
The change of AST over time was calculated and compared between groups. AST change was calculated as AST end - AST enrollment.
| units per liter | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| AST Change Over Time | -8.3 ± 25.5 | 2.9 ± 62.4 | 5.1 ± 49.8 |
The rate of change of ALT over time was compared between groups using mixed model analysis. Change of ALT was calculated as ALT at end of study compared to ALT at enrollment.
| units per liter | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| ALT Change Over Time | 8.7 ± 14.9 | 25.3 ± 53.3 | 17.2 ± 51.7 |
Alkaline phosphatase was recorded at enrollment and every 2 weeks. The change in alkaline phosphatase was calculated as alkaline phosphatase at end minus enrollment.
| units per liter | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Alkaline Phosphatase Change Over Time | 107.0 ± 146.9 | 166.1 ± 126.6 | 150.2 ± 139.9 |
All enrolled patients had serum triglyceride levels monitored at enrollment and weekly. The triglyceride level changes was calculated using values at the end of study compared to enrollment with mean and standard deviation calculated for each treatment group.
| mg/dL | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Triglyceride Level Over Time | -18.5 ± 31.0 | 013.3 ± 54.5 | 13.7 ± 48.0 |
GGT was documented at baseline and regularly intervals with level compared over time between groups. GGT was compared by treatment group for levels at end of study and enrollment.
| units per liter | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Gamma Glutamyl Transferase (GGT) Over Time | -0.8 ± 99.7 | 55.7 ± 73.3 | 37.3 ± 121.7 |
The rate of retinopathy of prematurity (ROP) was compared between groups. ROP was diagnosed based on ophthalmologist examination with all stages included.
| Participants | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Number of Patients With Retinopathy of Prematurity | 2 | 1 | 3 |
The rate of BPD was documented and compared between groups. BPD was diagnosed based on need for respiratory support at 28 days of age. All levels of severity were included.
| Participants | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease | 2 | 2 | 5 |
The length of stay at the level 4 NICU was compared between groups.
| days | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic |
|---|---|---|---|
| NICU Length of Stay | 72.2 ± 57.6 | 33.3 ± 46.0 | 40.2 ± 42.2 |
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes. Scores are separated into on schedule, monitoring zone, and below cutoff. These thresholds vary by aged screened. Possible screens used for this age group include 36 months, 42 months, and 48 months dependent on exact chronologic age screen completed. At 36 months communication 45-60 is on schedule; 35-40 monitoring, and \<35 below cutoff. For 42 months on schedule 40-60; monitoring 30-35; below cutoff \<35. For 48 months on schedule 45-60; monitoring 35-40; below cutoff \<35.
| score on a scale | Smoflipid 20% | Intralipid 20% Reduction |
|---|---|---|
| Three Year Development- Communication | 40.3 ± 22.4 | 41.2 ± 17.7 |
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcome, there are three possible scoring categories on schedule (normal), monitoring zone, below cutoff. Score thresholds by possible screens include: 36 months on schedule 50-60; monitoring 40-45; below cutoff \<40. 42 months on schedule 50-60; monitoring 40-45; below cutoff \<40. 48 months on schedule 45-60; monitoring 35-40; below cutoff \<35.
| score on a scale | Smoflipid 20% | Intralipid 20% Reduction |
|---|---|---|
| Three Year Development: Gross Motor | 43.0 ± 24.2 | 54.1 ± 8.19 |
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores show improved outcomes with three scoring categories: on schedule (normal), monitoring zone, and below cutoff. These thresholds vary by each category and screening age. Based on the possible screens for chronological age the score categories are: 36 months: 35-60 on schedule; 20-30 monitoring; \<20 below cutoff. 42 months: 35-60 on schedule; 20-30 monitoring; \<20 below cutoff. 48 months: 35-60 on schedule; 20-30 monitoring; \<20 below cutoff.
| score on a scale | Smoflipid 20% | Intralipid 20% Reduction |
|---|---|---|
| Three Year Development: Fine Motor | 32.2 ± 21.6 | 34.9 ± 19.1 |
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three possible score categories: on schedule (normal), monitoring zone, and below cutoff. Category thresholds vary by outcome category and age of screen. There are three possible screens that were used for this population, chosen based on chronologic age. The score categories based on age are: 36 months: 45-60 on schedule; 35-40 monitoring; \<35 below cutoff. 42 months: 40-60 on schdule; 30-35 monitoring; \<30 below cutoff. 48 months: 45-60 on schedule; 35-40 monitoring; \<35 below cutoff
| score on a scale | Smoflipid 20% | Intralipid 20% Reduction |
|---|---|---|
| Three Year Development: Problem Solving | 47.9 ± 19.5 | 47.3 ± 11.1 |
During the third year of chronological age an Ages and Stages questionnaire (ASQ) was completed by the parents. For each section the range of score possible is 0-60. Higher scores indicate improved outcomes with three score categories possible including on schedule (normal), monitoring zone, and below cutoff. These thresholds vary based on outcome measure and age of screen completed. Screen used depends on chronological age at screen. Score thresholds for each age include: 36 months: 45-60 on schedule; 35-40 monitoring; \<35 below cutoff. 42 months: 45-60 on schedule; 35-40 monitoring; \<35 below cutoff. 48 months: 40-60 on schedule; 30-40 monitoring; \<30 below cutoff.
| score on a scale | Smoflipid 20% | Intralipid 20% Reduction |
|---|---|---|
| Three Year Development: Personal Social | 46.5 ± 20.6 | 47.1 ± 10.5 |
Collected over Adverse event data was collected while patient was receiving study lipid, up to a maximum of 12 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Smoflipid 20% | 0/12 (0%) | 2/12 (16.7%) | 8/12 (66.7%) |
| Intralipid 20% Reduction | 0/12 (0%) | 2/12 (16.7%) | 6/12 (50%) |
| Event | Smoflipid 20% | Intralipid 20% Reduction |
|---|---|---|
| Rapid infusionProduct Issues | 1/12 | 1/12 |
| Intestinal perforationGastrointestinal disorders | 0/12 | 1/12 |
| gastrointestinal bleedGastrointestinal disorders | 1/12 | 0/12 |
| Event | Smoflipid 20% | Intralipid 20% Reduction |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 8/12 | 6/12 |
| Elevated GGTGastrointestinal disorders | 1/12 | 2/12 |
| Elevated LFTGastrointestinal disorders | 0/12 | 2/12 |
| HypoalbuminemiaMetabolism and nutrition disorders | 2/12 | 2/12 |
| HyperglycemiaMetabolism and nutrition disorders | 0/12 | 2/12 |
| HypophosphatemiaMetabolism and nutrition disorders | 1/12 | 2/12 |
| HypoglycemiaMetabolism and nutrition disorders | 1/12 | 2/12 |
| HypertriglyceridemiaMetabolism and nutrition disorders | 1/12 | 2/12 |
| HypochloremiaMetabolism and nutrition disorders | 2/12 | 0/12 |
| Metabolic alkalosisMetabolism and nutrition disorders | 2/12 | 0/12 |
| Age, Categorical(Participants) | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic | Total |
|---|---|---|---|---|
| <=18 years | 12 | 12 | 24 | 48 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(days) | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic | Total |
|---|---|---|---|---|
| Median | 4 (3.3 to 11.3) | 5 (4 to 5) | 2 (1 to 2.8) | 3.5 (2 to 5) |
| Sex: Female, Male(Participants) | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic | Total |
|---|---|---|---|---|
| Female | 7 | 5 | 9 | 21 |
| Male | 5 | 7 | 15 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 2 | 3 |
| Not Hispanic or Latino | 11 | 12 | 22 | 45 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 8 | 10 |
| White | 10 | 11 | 13 | 34 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Smoflipid 20% | Intralipid 20% Reduction | Intralipid 20% Historic | Total |
|---|---|---|---|---|
| United States | 12 | 12 | 24 | 48 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2018 to primary completion in Mar 2021, 27 months.
Results were first posted in Aug 2022, 1 year 4 months after primary completion.
Of 12 phase 3 interventional studies under Cholestasis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 64. This study's 27 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: SMOFlipid · Soybean oil, phospholipid emulsion