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



Status:Recruiting
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:December 2015
End Date:September 2016
Contact:Robert Segal, MD, FACP
Email:rsegal@discoverylabs.com
Phone:215-488-9450

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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)
We found this trial at
8
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Michael Cotten, MD
Phone: 919-597-8692
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar Carlo, MD
Phone: 205-996-6452
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Cristina Navarrete, MD
Phone: 305-585-6527
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Yona Nicolau, MD
Phone: 909-651-5002
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, CA
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Morristown, New Jersey 07960
Principal Investigator: John Ladino, MD
Phone: 973-971-4212
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Morristown, NJ
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Newark, Delaware 19713
Principal Investigator: Michael Antunes, MD
Phone: 302-733-2153
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Newark, DE
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Principal Investigator: Joseph W Kaempf, MD
Phone: 503-216-4655
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Portland, OR
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San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4966
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San Diego, CA
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