A MULTINATIONAL, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF LUCINACTANT FOR INHALATION IN PRETERM NEONATES 26 TO 32 WEEKS GESTATIONAL AGE WITH RESPIRATORY DISTRESS SYNDROME. - Lucinactant for inhalation

Discovery Laboratories Inc0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Signed ICF from legally authorized representative
•2. 26 to 32 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, respiratory insufficiency requiring an nCPAP of 5 to 6 cm H2O to maintain SpO2 of 90% to 95%, with an FiO2 of 0.25 to 0.45 that is clinically indicated for at least 30 minutes. Transient (<10 minutes) FiO2 excursions below 0.25 or above 0.45 do not reset the 30-minute requirement.

•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) 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), including and cranial/facial abnormalities that preclude delivery of nCPAP via nasal prongs, diagnosed antenatally or immediately after birth
•5. Other diseases or conditions, including those potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection, such as toxoplasmosis, rubella, cytomegalovirus, and herpes simplex [TORCH])
•6. A 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. A need for intubation and/or 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) Administration of any other surfactant agent
•c) Steroid treatment (exposure before birth is acceptable; ie, antenatal steroids)

发起方

Discovery Laboratories Inc