A Multinational, Multicenter, Masked, Randomized, Parallel Group, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation versus nCPAP alone in Preterm Neonates 26 to 32 Weeks Gestational Age with Respiratory Distress Syndrome.

Windtree Therapeutics, Inc.0 个研究点目标入组 130 人开始时间: 2019年3月26日最近更新: 2021年5月3日

适应症

试验速览

暂无简介。

•1. Signed ICF from legally authorized representative. It is recommended that consent is obtained antenatally (where permitted).
•2. Gestational age: 26 + 0/7 to 32 + 6/7 weeks PMA
•3. Successful implementation of non-invasive ventilation within 30 minutes after birth.
•4. Spontaneous breathing.
•5. Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis.
•6. Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 > 0.25 to = 0.35 to maintain SpO2 of 90% to 95%. Transient (<5 minutes) FiO2 excursions outside this range do not reset the time requirement.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 130
•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 > 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)
•11. Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema [PIE]) on the baseline chest radiograph, or diagnosed via ultrasound or illumination.

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