Comparison · NCT02772081-sae
Curosurf LISA vs Curosurf Endotracheal Tube: 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. Curosurf LISA vs Curosurf Endotracheal Tube: serious adverse events. Trial comparisons, record NCT02772081-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02772081-sae
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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 | 0.0526 | 0.00935 | 0.246 | wilson | |
| Risk in group 2 | 0.167 | 0.047 | 0.448 | wilson | |
| Risk difference, group 1 minus group 2 | -0.114 | -0.399 | 0.114 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.316 | 0.032 | 3.12 | log | |
| Odds ratio, group 1 over group 2 | 0.278 | 0.0223 | 3.46 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Curosurf LISA than on Curosurf Endotracheal Tube | 8.77 | 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 | Curosurf LISA | Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS.~A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed.~After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed.~LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea | 1 | 19 | EG000 |
| Group 2 | Curosurf Endotracheal Tube | Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS.~A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed.~After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed.~Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation | 2 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AEs) and serious AEs (SAEs) that started on or after the date of first randomized treatment administration up to the end of the main phase of the study. The main phase of the study included all time points from the pre-randomization period up to and including the follow-up visit at discharge home or 40 weeks PMA, whichever came first.
Source ClinicalTrials.gov
Trial
- Title
- A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
- NCT number
- NCT02772081
- Phases
- PHASE3
- Conditions
- Respiratory Distress Syndrome (RDS)
- Interventions
- LISA combination product (Curosurf+catheter CHF6440), Curosurf through conventional administration (endotracheal tube)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Results first posted
- 2023-11-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02772081?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.
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