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Comparison · NCT01709409-001ceb68

Curosurf (Group 1) vs BLES (Group 2): The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation

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. Curosurf (Group 1) vs BLES (Group 2): The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation. Trial comparisons, record NCT01709409-001ceb68. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01709409-001ceb68

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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 10.50.3550.645wilson
Risk in group 20.5780.4330.71wilson
Risk difference, group 1 minus group 2-0.0778-0.2740.127newcombe hybrid score
Risk ratio, group 1 over group 20.8650.5851.28log
Odds ratio, group 1 over group 20.7310.3141.7log
Number needed to treat, for one fewer participant with the outcome on Curosurf (Group 1) than on BLES (Group 2)12.9from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Curosurf (Group 1)
Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.
2142OG000
Group 2BLES (Group 2)Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.2645OG001

Outcome

Type
PRIMARY
Title
The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation
Description
1. rate on ventilator ≤40 per minute and~2. mean airway pressure ≤ 10 cm H20 and~3. fi02 ≤ 30%
Time frame
48 hours
Population

Source ClinicalTrials.gov

Trial

Title
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
NCT number
NCT01709409
Phases
PHASE3
Conditions
Respiratory Distress Syndrome
Interventions
Curosurf-Group1, BLES-group 2
Lead sponsor
Ottawa Hospital Research Institute
Results first posted
2017-10-25

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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