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



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

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A Multicenter, Randomized, Open-label, Controlled Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA

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.


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. Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen
saturation of 88% to 95% for at least 30 minutes within the first 20 hours after
birth.

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 exposure to an
investigational medical device, any other surfactant agent, steroid treatment after
birth.
We found this trial at
7
sites
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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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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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Dan Stewart, MD
Phone: 502-629-5038
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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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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San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4966
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San Diego, CA
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