Comparison · NCT00004500-e5273c83
Lucinactant vs Standard Care: Number of Participants With Air Leaks
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. Lucinactant vs Standard Care: Number of Participants With Air Leaks. Trial comparisons, record NCT00004500-e5273c83. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00004500-e5273c83
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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 | 0.0146 | 0.173 | wilson | |
| Risk in group 2 | 0 | 0 | 0.11 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0526 | -0.064 | 0.173 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Lucinactant than on Standard Care | 19 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lucinactant | Lucinactant via bronchoaveolar lavage | 2 | 38 | OG000 |
| Group 2 | Standard Care | Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization | 0 | 31 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Air Leaks
- Description
- Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium
- Time frame
- 28 days
- Population
Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat).
Source ClinicalTrials.gov
Trial
- Title
- Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
- NCT number
- NCT00004500
- Phases
- PHASE3
- Conditions
- Meconium Aspiration
- Interventions
- Lucinactant, Standard Care
- Lead sponsor
- Windtree Therapeutics
- Results first posted
- 2012-05-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00004500?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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