Trial · NCT00578734
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
NCT00578734, Phase 2, Completed, Windtree Therapeutics; results first posted 2012-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old. Trials, record NCT00578734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578734
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
- NCT number
- NCT00578734
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 165 participants, actual
- Lead sponsor
- Windtree Therapeutics
- Conditions
- Acute Hypoxemic Respiratory Failure
- Interventions
- Lucinactant, Sham Comparator
- First posted
- 2007-12-21
- Last updated
- 2012-05-03
- Results first posted
- 2012-04-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Mechanical Ventilation Through 14 Days | Up to 14 Days | Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days. |
| Secondary | Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Up to 14 days |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Mechanical Ventilation Through 14 Days | Up to 14 Days | The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses. | days | LEAST_SQUARES_MEAN |
| SECONDARY | Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Up to 14 days | The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses. | days | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Mechanical Ventilation Through 14 Days | Lucinactant | 4.0 | 95% Confidence Interval 3.5 to 4.6 | days | |
| Duration of Mechanical Ventilation Through 14 Days | Sham Air | 4.5 | 95% Confidence Interval 3.9 to 5.2 | days | |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Lucinactant | Ventilator-free days | 5.2 | 95% Confidence Interval 4.6 to 5.9 | days |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Sham Air | Ventilator-free days | 4.6 | 95% Confidence Interval 4.1 to 5.3 | days |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Lucinactant | Duration in Pediatric Intensive Care Unit (PICU) | 6.2 | 95% Confidence Interval 5.4 to 7.0 | days |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Sham Air | Duration in Pediatric Intensive Care Unit (PICU) | 6.7 | 95% Confidence Interval 5.9 to 7.6 | days |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Lucinactant | Duration of Supplemental Oxygen | 7.7 | 95% Confidence Interval 6.8 to 8.7 | days |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Sham Air | Duration of Supplemental Oxygen | 7.9 | 95% Confidence Interval 7.0 to 9.0 | days |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Lucinactant | Duration of Hospitalization | 10.0 | 95% Confidence Interval 9.1 to 11.1 | days |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days | Sham Air | Duration of Hospitalization | 9.7 | 95% Confidence Interval 8.8 to 10.7 | days |
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 | Lucinactant | 84 | |
| Overall Study | STARTED | Sham Air | 81 | |
| Overall Study | COMPLETED | Lucinactant | 84 | |
| Overall Study | COMPLETED | Sham Air | 81 | |
| Overall Study | NOT COMPLETED | Lucinactant | 0 | |
| Overall Study | NOT COMPLETED | Sham Air | 0 |
Source ClinicalTrials.gov
Adverse events98
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 | Anaemia | Blood and lymphatic system disorders | Lucinactant | 11 | 84 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Sham Air | 19 | 81 | 21 |
| other | Bradycardia | Cardiac disorders | Lucinactant | 4 | 84 | 4 |
| other | Bradycardia | Cardiac disorders | Sham Air | 9 | 81 | 10 |
| other | Abdominal distension | Gastrointestinal disorders | Lucinactant | 5 | 84 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | Sham Air | 3 | 81 | 3 |
| other | Drug withdrawal syndrome | General disorders | Lucinactant | 4 | 84 | 4 |
| other | Drug withdrawal syndrome | General disorders | Sham Air | 4 | 81 | 4 |
| other | Oedema | General disorders | Lucinactant | 2 | 84 | 2 |
| other | Oedema | General disorders | Sham Air | 5 | 81 | 6 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lucinactant | ||
| Total, all-cause mortality | Sham Air | ||
| Total, other adverse events | Lucinactant | 65 | 84 |
| Total, other adverse events | Sham Air | 62 | 81 |
| Total, serious adverse events | Lucinactant | 20 | 84 |
| Total, serious adverse events | Sham Air | 14 | 81 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22791092 | DERIVED |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lucinactant vs Sham Air: serious adverse events |
Source 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/NCT00578734
GET https://conductscience.org/api/trials/v1/NCT00578734/events?page=2