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NCT02636868 · ClinicalTrials.gov registry record · Phase 2
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
A Phase 2 study of Respiratory Distress Syndrome, sponsored by Windtree Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 221
- Enrollment target
- 20
- Study locations
NCT02636868: Completed Phase 2 study of Respiratory Distress Syndrome, sponsored by Windtree Therapeutics.
NCT02636868 is a Phase 2 study of Respiratory Distress Syndrome that has completed, run by Windtree Therapeutics. The registered enrollment target is 221 participants, roughly in line with the 207-participant average among 8 other Respiratory Distress Syndrome trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02636868, a Phase 2 study of Respiratory Distress Syndrome, has completed, sponsored by Windtree Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 221 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.
Primary Outcome
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure
Conditions Studied
Interventions
- DRUG Lucinactant delivered via investigational delivery device
- DRUG nCPAP
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital of Orange County - Orange
- Sharp Mary Birch Hospital for Women and Newborns - San Diego
North Carolina
- Duke University Medical Center - Durham
- Brody School of Medicine at ECU - Greenville
- New Hanover Regional Medical Center - Wilmington
New York
- Albany Medical Center - Albany
- Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) - New York
Ohio
- Case Western Reserve University (Rainbow Babies Hosp.) - Cleveland
- Ohio State University - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- Univ. of Arkansas Medical Center - Little Rock
Delaware
- Christiana Care Health System - Newark
Florida
- University of Miami Holtz Children's Hospital - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2015-12 |
| Est. Completion | 2019-08-06 |
| Phase | Phase 2 |
What the finished NCT02636868 record still lists
NCT02636868 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 207-participant average among 8 other Respiratory Distress Syndrome trials with a reported enrollment target.
The record links to 1 condition, with Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Lucinactant delivered via investigational delivery device is the first listed.
NCT02636868 names 20 study sites across 14 states, led by California, North Carolina, New York.
Frequently Asked Questions
What is clinical trial NCT02636868 about?
NCT02636868 is a clinical study titled "The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age". The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syn...
What is the current status of trial NCT02636868?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 221 participants. The study started on 2015-12. Estimated completion is 2019-08-06.
What conditions does trial NCT02636868 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome.
What interventions are being tested in trial NCT02636868?
The interventions under investigation include: Lucinactant delivered via investigational delivery device (DRUG), nCPAP (DRUG).
Who is sponsoring clinical trial NCT02636868?
This trial is sponsored by Windtree Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02636868 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Respiratory Distress Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02636868's enrollment target sits among peer trials
221 4th of 8 higher than 5 of 8 other Respiratory Distress Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Distress Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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