A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 26 to 28 Weeks PMA.

Windtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)0 sites64 target enrollmentStarted: February 25, 2016Last updated: August 21, 2017

Conditions

Trial Snapshot

No summary available.

•1.Signed ICF from legally authorized representative;
•2.Gestational age 26 to 28 completed weeks PMA;
•3.Successful implementation of controlled nCPAP within 90 minutes after birth;
•4.Spontaneous breathing;
•5.Chest radiograph consistent with RDS;
•6.Within the first 20 hours after birth, requires an nCPAP of 5 to 6 cm H2O to maintain SpO2 of 88% to 95% with an 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 do not reset the 30 minute requirement.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 64
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Heart rate that cannot be stabilized above 100 beats per minutes within 5 minutes of birth;
•2.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;
•3.A 5 minute Apgar score < 5;
•4.Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth;
•5.Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH);
•6.Known or suspected chromosomal abnormality or syndrome;
•7.Premature rupture of membranes (PROM) > 2 weeks;
•8.Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis;
•9.Need for endotracheal intubation and/or mechanical ventilation;
•10.Has been administered any the following:
•a)Another investigational agent or investigational medical device,
•b)Administration of any other surfactant agent,
•c)Steroid treatment (exposure before birth is acceptable).

Sponsor

Windtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)