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

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 64
• Participant gender: Both

Summary

The primary objective of this study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosolized dose in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS) compared to neonates receiving nCPAP alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Windtree Therapeutics
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Last Updated: 2016-09-01

Criteria

Inclusion Criteria:

1. Informed consent from a legally authorized representative.

2. Gestational age 26 to 28 completed weeks post menstrual age (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 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.

Exclusion Criteria:

1. Heart rate that cannot be stabilized above 100 beats/minute 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. Prolong 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 mechanical ventilation.

10. Has been administered: another investigational agent or investigational medical device, any other surfactant agent, steroid treatment after birth.