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The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
NCT02636868 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02636868
The ClinicalTrials.gov registry entry for NCT02636868 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Windtree Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02636868 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, North Carolina, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02636868?
The interventions under investigation include: Lucinactant delivered via investigational delivery device (DRUG), nCPAP (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02636868?
This trial is sponsored by Windtree Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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