Comparison · NCT04264156-7e2e2dac
Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: Number of Participants With Common Complications of Prematurity
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. Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: Number of Participants With Common Complications of Prematurity. Trial comparisons, record NCT04264156-7e2e2dac. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04264156-7e2e2dac
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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 | 0.818 | 0.523 | 0.949 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.182 | -0.477 | 0.622 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.818 | 0.619 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Lucinactant (160 mg/kg) + nCPAP than on nCPAP Only | 5.5 | 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 | Lucinactant (160 mg/kg) + nCPAP | Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth~Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP. | 9 | 11 | OG000 |
| Group 2 | nCPAP Only | nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time~nCPAP Only: Nasal CPAP Alone | 1 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Common Complications of Prematurity
- Description
Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity.
- Time frame
- 36 weeks PMA
- Population
- Intent-to-Treat
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
- NCT number
- NCT04264156
- Phases
- PHASE2
- Conditions
- Respiratory Distress Syndrome, Newborn
- Interventions
- Lucinactant for Inhalation, nCPAP Only
- Lead sponsor
- Windtree Therapeutics
- Results first posted
- 2023-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04264156?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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