Trial · NCT04264156
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
NCT04264156, Phase 2, Terminated, Windtree Therapeutics; results first posted 2023-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age. Trials, record NCT04264156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04264156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
- NCT number
- NCT04264156
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Windtree Therapeutics
- Conditions
- Respiratory Distress Syndrome, Newborn
- Interventions
- Lucinactant for Inhalation, nCPAP Only
- First posted
- 2020-02-11
- Last updated
- 2023-05-24
- Results first posted
- 2023-05-24
- Limitations and caveats
- Study was terminated early leading to a very small number of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Respiratory Failure or Death | 28 days of life | Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration |
| Secondary | Number With BPD | 36 weeks post-menstrual age (PMA) | Number of participants with bronchopulmonary dysplasia (BPD) |
| Secondary | Mortality | 36 weeks PMA or 28 days of life (whichever is later) | All-cause mortality |
| Secondary | Number of Participants With Common Complications of Prematurity | 36 weeks PMA | Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Respiratory Failure or Death | 28 days of life | Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number With BPD | 36 weeks post-menstrual age (PMA) | Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mortality | 36 weeks PMA or 28 days of life (whichever is later) | Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Common Complications of Prematurity | 36 weeks PMA | Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Respiratory Failure or Death | Lucinactant (160 mg/kg) + nCPAP | 6 | Participants | ||
| Number of Participants With Respiratory Failure or Death | nCPAP Only | 0 | Participants | ||
| Number With BPD | Lucinactant (160 mg/kg) + nCPAP | 0 | Participants | ||
| Number With BPD | nCPAP Only | 0 | Participants | ||
| Mortality | Lucinactant (160 mg/kg) + nCPAP | 0 | Participants | ||
| Mortality | nCPAP Only | 0 | Participants | ||
| Number of Participants With Common Complications of Prematurity | Lucinactant (160 mg/kg) + nCPAP | 9 | Participants | ||
| Number of Participants With Common Complications of Prematurity | nCPAP Only | 1 | 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 | Lucinactant (160 mg/kg) + nCPAP | 11 | |
| Overall Study | STARTED | nCPAP Only | 1 | |
| Overall Study | COMPLETED | Lucinactant (160 mg/kg) + nCPAP | 11 | |
| Overall Study | COMPLETED | nCPAP Only | 1 | |
| Overall Study | NOT COMPLETED | Lucinactant (160 mg/kg) + nCPAP | 0 | |
| Overall Study | NOT COMPLETED | nCPAP Only | 0 |
Source ClinicalTrials.gov
Adverse events106
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 | Anemia neonatal | Blood and lymphatic system disorders | Lucinactant (160 mg/kg) + nCPAP | 8 | 11 | 9 |
| other | Anemia neonatal | Blood and lymphatic system disorders | nCPAP Only | 0 | 1 | 0 |
| other | Coagulation disorder neonatal | Blood and lymphatic system disorders | Lucinactant (160 mg/kg) + nCPAP | 1 | 11 | 1 |
| other | Coagulation disorder neonatal | Blood and lymphatic system disorders | nCPAP Only | 0 | 1 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Lucinactant (160 mg/kg) + nCPAP | 1 | 11 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | nCPAP Only | 0 | 1 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Lucinactant (160 mg/kg) + nCPAP | 1 | 11 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | nCPAP Only | 0 | 1 | 0 |
| other | Tachycardia | Cardiac disorders | Lucinactant (160 mg/kg) + nCPAP | 2 | 11 | 2 |
| other | Tachycardia | Cardiac disorders | nCPAP Only | 0 | 1 | 0 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lucinactant (160 mg/kg) + nCPAP | 0 | 11 |
| Total, all-cause mortality | nCPAP Only | 0 | 1 |
| Total, other adverse events | Lucinactant (160 mg/kg) + nCPAP | 11 | 11 |
| Total, other adverse events | nCPAP Only | 1 | 1 |
| Total, serious adverse events | Lucinactant (160 mg/kg) + nCPAP | 2 | 11 |
| Total, serious adverse events | nCPAP Only | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: Number of Participants With Respiratory Failure or Death | Trial comparisons |
| Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: Number of Participants With Common Complications of Prematurity | Trial comparisons |
| Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: Mortality | Trial comparisons |
| Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: Number With BPD | Trial comparisons |
| Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: deaths from any cause | Trial comparisons |
| Lucinactant (160 mg/kg) + nCPAP vs nCPAP Only: 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/NCT04264156
GET https://conductscience.org/api/trials/v1/NCT04264156/events?page=2