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Completed Phase 2 Interventional Results available

The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

ClinicalTrials.gov ID: NCT02636868

Public ClinicalTrials.gov record NCT02636868. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 1:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess The Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age With Respiratory Distress Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02636868
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Windtree Therapeutics
Industry
Enrollment
221 participants

Conditions and interventions

Eligibility (public fields only)

Age range
26 Weeks to 32 Weeks
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2015 (Actual)
Primary completion
Jul 2017 (Actual)
Completion
Aug 6, 2019 (Actual)
Last update posted
Apr 23, 2021

2015 – 2019

United States locations

U.S. sites
22
U.S. states
14
U.S. cities
21
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35249 —
Univ. of Arkansas Medical Center Little Rock Arkansas 72202 —
Loma Linda University Medical Center Loma Linda California 92354 —
Children's Hospital of Orange County Orange California 92868 —
Sharp Mary Birch Hospital for Women and Newborns San Diego California 92123 —
Christiana Care Health System Newark Delaware 19713 —
University of Miami Holtz Children's Hospital Miami Florida 33136 —
University of Michigan Health System Ann Arbor Michigan 48109 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
University of Nebraska Medical Center Omaha Nebraska 68105 —
Albany Medical Center Albany New York 12208 —
Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) New York New York 10032 —
Duke University Medical Center Durham North Carolina 27710 —
Brody School of Medicine at ECU Greenville North Carolina 27834 —
New Hanover Regional Medical Center Wilmington North Carolina 28401 —
Case Western Reserve University (Rainbow Babies Hosp.) Cleveland Ohio 44106 —
Ohio State University Columbus Ohio 43210 —
Providence St. Vincent Medical Center Portland Oregon 97225 —
Women and Infants Hospital Providence Rhode Island 02905 —
Baylor University Medical Center Dallas Texas 75246 —
Cook Children's Hospital Fort Worth Texas 76104 —
Texas Health Harris Methodist Hospital Fort Worth Texas 76104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02636868, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 23, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02636868 live on ClinicalTrials.gov.

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