Comparison · NCT03058666-e0367388
Aerosolized Calfactant vs Usual Care: Intubation and Instillation of Liquid Surfactant
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Aerosolized Calfactant vs Usual Care: Intubation and Instillation of Liquid Surfactant. Trial comparisons, record NCT03058666-e0367388. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03058666-e0367388
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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 | 0.286 | 0.233 | 0.346 | wilson | |
| Risk in group 2 | 0.508 | 0.445 | 0.572 | wilson | |
| Risk difference, group 1 minus group 2 | -0.222 | -0.305 | -0.135 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.563 | 0.445 | 0.713 | log | |
| Odds ratio, group 1 over group 2 | 0.388 | 0.266 | 0.566 | log | |
| Number needed to treat, for one fewer participant with the outcome on Aerosolized Calfactant than on Usual Care | 4.5 | 3.28 | 7.42 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aerosolized Calfactant | 1. NICU Patients with a clinical diagnosis of RDS~2. Inspired oxygen ≥21% to maintain adequate oxygen saturation~3. Not Intubated~4. Requiring Nasal continuous positive airway pressure~Aerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.~Solarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. | 69 | 241 | OG000 |
| Group 2 | Usual Care | There will be no protocol driven interventions in the usual care group. | 120 | 236 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Intubation and Instillation of Liquid Surfactant
- Description
- Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.
- Time frame
- 72 hours
- Population
- All enrolled patients.
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
- NCT number
- NCT03058666
- Phases
- PHASE3
- Conditions
- Respiratory Distress Syndrome
- Interventions
- Aerosolized Calfactant, Solarys
- Lead sponsor
- ONY
- Results first posted
- 2024-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03058666?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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