Comparison · NCT02579265-sae
Intralipid® 20% vs Smoflipid 20%: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Intralipid® 20% vs Smoflipid 20%: serious adverse events. Trial comparisons, record NCT02579265-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02579265-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0641 | 0.0277 | 0.141 | wilson | |
| Risk in group 2 | 0.0964 | 0.0497 | 0.179 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0323 | -0.122 | 0.0581 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.665 | 0.227 | 1.95 | log | |
| Odds ratio, group 1 over group 2 | 0.642 | 0.201 | 2.05 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Intralipid® 20% than on Smoflipid 20% | 31 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 5 | 78 | EG000 |
| Group 2 | 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. | 8 | 83 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
- NCT number
- NCT02579265
- Phases
- PHASE3
- Conditions
- Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
- Interventions
- Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
- Lead sponsor
- Fresenius Kabi
- Results first posted
- 2022-01-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02579265?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02579265-sae