Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA

Stopped early · Phase 2

Conditions studied: Respiratory Distress Syndrome

In brief

This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.

Key facts

Study ID

NCT02528318

Run by

Windtree Therapeutics

People needed

48

Starts

2015-08-01

Expected to finish

2017-08-11

Last updated by the study team

2019-07-23

Who can join

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

You may qualify if…

• Informed consent from a legally authorized representative.
• Gestational age 26 to 28 completed weeks post menstrual age (PMA).
• Successful implementation of controlled nCPAP within 90 minutes after birth.
• Spontaneous breathing.
• Chest radiograph consistent with RDS.
• Within the first 20 hours after birth, have an nCPAP of 5 to 6 cm H2O to maintain oxygen saturation measured by pulse oximetry (SpO2) of 88% to 95% with a fraction of inspired oxygen (FiO2) of 0.25 to 0.50 that is clinically indicated for at least 30 minutes. Transient (<10 minutes) FiO2 excursions below 0.25 or above 0.50 did not reset the 30 minute requirement.

You may not qualify if…

• Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth.
• Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface.
• A 5 minute Apgar score < 5.
• Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth.
• Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH).
• Known or suspected chromosomal abnormality or syndrome.
• Premature rupture of membranes (PROM) > 2 weeks.
• Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis.
• Need for endotracheal intubation and mechanical ventilation.
• Has been administered: another investigational agent or investigational medical device, any other surfactant agent, steroid treatment after birth.

Where it is running

• Loma Linda University Medical Center — Loma Linda, 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 — Miami, Florida, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Columbia University College of Physicians and Surgeons, New York Presbyterian Hospital - Morgan Stanley Children's Hospital — New York, New York, United States
• New Hanover Regional Medical Center — Wilmington, North Carolina, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Foothills Medical Centre — Calgary, Alberta, Canada
• Royal Alexandria Hospital — Edmonton, Alberta, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Montreal Children's Hospital — Montreal, Quebec, Canada
• Hospital Dr Sotero Del Rio — Santiago, Chile
• Hospital San Juan de Dios — Santiago, Chile
• Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii — Poznan, Greater Poland Voivodeship, Poland
• S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N — Bydgoszcz, Kujawsko-pomorksie, Poland
• Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii — Warsaw, Masovian Voivodeship, Poland
• Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii — Lodz, Łódź Voivodeship, Poland

Full record on ClinicalTrials.gov

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