Trial · NCT02579265
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
NCT02579265, Phase 3, Terminated, Fresenius Kabi; results first posted 2022-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants. Trials, record NCT02579265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02579265
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
- NCT number
- NCT02579265
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 204 participants, actual
- Lead sponsor
- Fresenius Kabi
- Conditions
- Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
- Interventions
- Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
- First posted
- 2015-10-19
- Last updated
- 2022-01-05
- Results first posted
- 2022-01-05
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | 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 | |
| Secondary | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl | The numbers in the subgroups refer to 100% | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Body Weight (Change From Baseline) | Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up) | The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Full Enteral or Oral Feeds | Day 29/end of treatment, if continued: Day 85/end of treatment | The Standard Deviation for Time to Event was not calculated. NA=Not available | Time to event in days | MEDIAN |
| SECONDARY | 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 | Over time analysis of laboratory parameters were assessed at all timepoints as available | ug/mL | MEAN |
| SECONDARY | Length of Stay in Hospital | Day 1- Follow up (7 days after end of treatment) | Median time (days) until discharge | MEDIAN | |
| SECONDARY | Ratio of Independent Bloodstream Infections to Number of Days on Study Medication | Day 1-29 or -85 if continued + Follow-up | ratio | MEAN | |
| SECONDARY | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Who Complete PN Treatment Without Lipid Minimization | Day 1-29 or -85 if continued + Follow-up | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group386
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Intralipid® 20% | Combined | 3 | Participants | |
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 | Smoflipid 20% | Combined | 2 | Participants | |
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 | Intralipid® 20% | NEC | 0 | Participants | |
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 | Smoflipid 20% | NEC | 1 | Participants | |
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 | Intralipid® 20% | No NEC | 3 | Participants | |
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 | Smoflipid 20% | No NEC | 1 | Participants | |
| Body Weight (Change From Baseline) | Intralipid® 20% | Baseline / Low | 12 | Participants | |
| Body Weight (Change From Baseline) | Smoflipid 20% | Baseline / Low | 20 | Participants | |
| Body Weight (Change From Baseline) | Intralipid® 20% | Baseline / Normal | 62 | Participants | |
| Body Weight (Change From Baseline) | Smoflipid 20% | Baseline / Normal | 62 | Participants |
1 to 10 of 386Source ClinicalTrials.gov
See all 386 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Smoflipid 20% | 83 | |
| Overall Study | STARTED | Intralipid® 20% | 78 | |
| Overall Study | COMPLETED | Smoflipid 20% | 33 | |
| Overall Study | COMPLETED | Intralipid® 20% | 33 | |
| Overall Study | NOT COMPLETED | Smoflipid 20% | 50 | |
| Overall Study | NOT COMPLETED | Intralipid® 20% | 45 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Intralipid® 20% | 8 | 78 | 11 |
| other | Anemia | Blood and lymphatic system disorders | Smoflipid 20% | 4 | 83 | 5 |
| other | Anemia neonatal | Blood and lymphatic system disorders | Intralipid® 20% | 17 | 78 | 20 |
| other | Anemia neonatal | Blood and lymphatic system disorders | Smoflipid 20% | 15 | 83 | 16 |
| other | Tachycardia | Cardiac disorders | Intralipid® 20% | 4 | 78 | 6 |
| other | Tachycardia | Cardiac disorders | Smoflipid 20% | 3 | 83 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Intralipid® 20% | 3 | 78 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Smoflipid 20% | 7 | 83 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Intralipid® 20% | 5 | 78 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Smoflipid 20% | 4 | 83 | 4 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intralipid® 20% | 1 | 78 |
| Total, all-cause mortality | Smoflipid 20% | 1 | 83 |
| Total, other adverse events | Intralipid® 20% | 55 | 78 |
| Total, other adverse events | Smoflipid 20% | 59 | 83 |
| Total, serious adverse events | Intralipid® 20% | 5 | 78 |
| Total, serious adverse events | Smoflipid 20% | 8 | 83 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39374788 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intralipid® 20% vs Smoflipid 20%: Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication | Trial comparisons |
| Intralipid® 20% vs Smoflipid 20%: deaths from any cause | Trial comparisons |
| Intralipid® 20% vs Smoflipid 20%: Number of Patients Who Complete PN Treatment Without Lipid Minimization | Trial comparisons |
| Intralipid® 20% vs Smoflipid 20%: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02579265
GET https://conductscience.org/api/trials/v1/NCT02579265/results?page=2