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

Completed · Phase 2

Conditions studied: Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT02636868

Run by

Windtree Therapeutics

People needed

221

Starts

2015-12-01

Expected to finish

2019-08-06

Last updated by the study team

2021-04-23

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form (ICF) from legally authorized representative
• 26 0/7 to 32 6/7 completed weeks gestation PMA
• Successful implementation of non-invasive support or ventilation within 90 minutes after birth
• Spontaneous breathing
• Chest radiograph consistent with RDS
• Within the first 20 hours after birth requires an nCPAP of 5 to 7 centimeters water (cmH2O) with a fraction of inspired oxygen (FiO2) of ≥ 0.25 (>0.21 for neonates 26-28 weeks PMA) to 0.40 that is clinically indicated for at least 30 minutes to maintain oxygen by pulse oximetry (SpO2) of 90% to 95%. Transient (<10 minutes) FiO2 excursions outside this range do not reset the 30-minute requirement.

You may not qualify if…

• A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5 minutes of birth
• Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface
• A 5 minute Apgar score < 5
• Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth
• Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (e.g. congenital heart disease, hydrops fetalis or congenital infection)
• A known or suspected chromosomal abnormality or syndrome
• Premature rupture of membranes (PROM) > 3 weeks
• Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
• A need for intubation and/or mechanical ventilation at any time before enrollment into the study
• The administration (or plan for administration) of any the following:
• Another investigational agent or investigational medical device
• Any other surfactant agent
• Systemic corticosteroids (other than antenatal steroids already received)
• Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema (PIE)) on the baseline chest radiograph

Where it is running

• Univ. of Arkansas Medical Center — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States
• Christiana Care Health System — Newark, Delaware, United States
• University of Miami Holtz Children's Hospital — Miami, Florida, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Albany Medical Center — Albany, New York, United States
• Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Brody School of Medicine at ECU — Greenville, North Carolina, United States
• New Hanover Regional Medical Center — Wilmington, North Carolina, United States
• Case Western Reserve University (Rainbow Babies Hosp.) — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Cook Children's Hospital — Fort Worth, Texas, United States
• Texas Health Harris Methodist Hospital — Fort Worth, Texas, United States
• Foothills Medical Centre — Calgary, Alberta, Canada
• Royal Alexandra Hospital — Edmonton, Alberta, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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