Trial to Assess the Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Age Range:Any
Start Date:December 2015
End Date:September 2016
Contact:Robert Segal, MD, FACP

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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

The primary objective of this study is to evaluate the safety and efficacy of lucinactant
for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32
weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP)
for Resipiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.

Inclusion Criteria:

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.

Exclusion Criteria:

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:

- Another investigational agent or investigational medical device

- Administration of any other surfactant agent

- Steroid treatment (exposure before birth is acceptable; ie, antenatal steroids)
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