A MULTINATIONAL, MULTICENTER, MASKED, RANDOMIZED, CONTROLLEDSTUDY TO ASSESS THE SAFETY AND EFFICACY OF LUCINACTANT FORINHALATION IN PRETERM NEONATES 26 TO 32 WEEKS GESTATIONAL AGEWITH RESPIRATORY DISTRESS SYNDROME.

Windtree Therapeutics, Inc0 个研究点目标入组 240 人开始时间: 2016年1月7日最近更新: 2020年6月2日

试验速览

暂无简介。

•1. Signed ICF from legally authorized representative
•2. 26 0/7 to 32 6/7 completed weeks' gestation PMA
•3. Successful implementation of non-invasive support or ventilation
•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 7 cm H2O with an FiO2 =0.25 (>0.21 for neonates 26-28 weeks PMA) to 0.4 that is clinically indicated for at least 30 minutes to maintain SpO2 of 90% to 95%. Transient (<10 minutes) FiO2 excursions below 0.25 or above 0.45 do not reset the 30-minute requirement.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 240
•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. A heart rate that cannot be stabilized above 100 beats per minute
•(bpm) within 5 minutes of birth
•2. Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface
•3. A 5 minute Apgar score < 5
•4. Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth
•5. Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (eg, congenital heart disease, hydrops fetalis or congenital infection)
•6. A known or suspected chromosomal abnormality or syndrome
•7. Premature rupture of membranes (PROM) >3 weeks
•8. Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
•9. A need for intubation and/or invasive mechanical ventilation at any
•time before enrollment into the study
•10. The administration (or plan for administration) of any the following:
•a) Another investigational agent or investigational medical device
•b) Any other surfactant agent
•c) Systemic corticosteroids (other than antenatal steroids already received)
•11. Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema [PIE]) on the baseline chest

发起方

Windtree Therapeutics, Inc