Trial · NCT01709409
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
NCT01709409, Phase 3, Completed, Ottawa Hospital Research Institute; results first posted 2017-10-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants. Trials, record NCT01709409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01709409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
- NCT number
- NCT01709409
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 88 participants, actual
- Lead sponsor
- Ottawa Hospital Research Institute
- Conditions
- Respiratory Distress Syndrome
- Interventions
- Curosurf-Group1, BLES-group 2
- First posted
- 2012-10-18
- Last updated
- 2017-10-25
- Results first posted
- 2017-10-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 48 hours | 1. rate on ventilator ≤40 per minute and 2. mean airway pressure ≤ 10 cm H20 and 3. fi02 ≤ 30% |
| Secondary | To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups. | 36 weeks GA | 1\. Extubation failure |
| Secondary | Curosurf-01 | 36 weeks GA | 2\. Duration of first intubation (in hours/days) |
| Secondary | Curosurf-01 | 36 weeks GA | 3\. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement |
| Secondary | Curosurf-01 | 36 weeks GA | 4\. Number of doses of surfactant received |
| Secondary | Curosurf-01 | 36 weeks GA | 5\. Adverse events during or after administration of surfactant |
| Secondary | Curosurf-01 | 36 Weeks GA | 6\. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA |
| Secondary | Curosurf-01 | 36 weeks GA | 7\. Mortality prior to discharge |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 48 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups. | 36 weeks GA | |||
| SECONDARY | Curosurf-01 | 36 weeks GA | |||
| SECONDARY | Curosurf-01 | 36 weeks GA | |||
| SECONDARY | Curosurf-01 | 36 weeks GA | |||
| SECONDARY | Curosurf-01 | 36 weeks GA | |||
| SECONDARY | Curosurf-01 | 36 Weeks GA | |||
| SECONDARY | Curosurf-01 | 36 weeks GA |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Curosurf (Group 1) | 21 | Participants | ||
| 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 | BLES (Group 2) | 26 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Curosurf (Group 1) | 43 | |
| Overall Study | STARTED | BLES (Group 2) | 45 | |
| Overall Study | COMPLETED | Curosurf (Group 1) | 42 | |
| Overall Study | COMPLETED | BLES (Group 2) | 45 | |
| Overall Study | NOT COMPLETED | Curosurf (Group 1) | 1 | |
| Overall Study | NOT COMPLETED | BLES (Group 2) | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | pulmonary interstitial emphysema | Respiratory, thoracic and mediastinal disorders | Curosurf (Group 1) | 1 | 42 | 1 |
| other | pulmonary interstitial emphysema | Respiratory, thoracic and mediastinal disorders | BLES (Group 2) | 1 | 45 | 1 |
| serious | severe airway obstruction | Respiratory, thoracic and mediastinal disorders | Curosurf (Group 1) | 0 | 42 | 0 |
| serious | severe airway obstruction | Respiratory, thoracic and mediastinal disorders | BLES (Group 2) | 5 | 45 | 5 |
| serious | air leak | Reproductive system and breast disorders | Curosurf (Group 1) | 3 | 42 | 3 |
| serious | air leak | Reproductive system and breast disorders | BLES (Group 2) | 5 | 45 | 5 |
| serious | pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Curosurf (Group 1) | 2 | 42 | 2 |
| serious | pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | BLES (Group 2) | 3 | 45 | 3 |
| serious | needing CPR | Cardiac disorders | Curosurf (Group 1) | 0 | 42 | 0 |
| serious | needing CPR | Cardiac disorders | BLES (Group 2) | 2 | 45 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Curosurf (Group 1) | ||
| Total, all-cause mortality | BLES (Group 2) | ||
| Total, other adverse events | Curosurf (Group 1) | 1 | 42 |
| Total, other adverse events | BLES (Group 2) | 1 | 45 |
| Total, serious adverse events | Curosurf (Group 1) | 5 | 42 |
| Total, serious adverse events | BLES (Group 2) | 11 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28472058 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
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 |
| Curosurf (Group 1) vs BLES (Group 2): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01709409
GET https://conductscience.org/api/trials/v1/NCT01709409/registered