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Comparison · NCT04264156-deaths

Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: deaths from any cause

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: deaths from any cause. Trial comparisons, record NCT04264156-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04264156-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.259wilson
Risk in group 2000.793wilson
Risk difference, group 1 minus group 20-0.7930.259newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Lucinactant (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.
011EG000
Group 2nCPAP OnlynCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time~nCPAP Only: Nasal CPAP Alone01EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.

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

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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