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Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Discovery Laboratories
ClinicalTrials.gov Identifier:
NCT00807235
First received: December 10, 2008
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
Results First Received: April 2, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Respiratory Distress Syndrome
Intervention: Drug: Aerosolized lucinactant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Neonates were enrolled between January and August, 2005. This was an open-label study with 2 treatment groups (Regimen 1 and Regimen 2). Eligible neonates were sequentially enrolled and stratified by GA into 2 strata for each regimen. For each regimen, enrollment in Stratum 1 (30 to 32 GA) was completed before enrollment in Stratum 2 (28 to 29 GA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lucinactant - 3 Hour Interval Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
Lucinactant - 1 Hour Interval Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour

Participant Flow:   Overall Study
    Lucinactant - 3 Hour Interval     Lucinactant - 1 Hour Interval  
STARTED     11     6  
COMPLETED     10     6  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Lucinactant - 3 Hour Interval Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
Lucinactant - 1 Hour Interval Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
Total Total of all reporting groups

Baseline Measures
    Lucinactant - 3 Hour Interval     Lucinactant - 1 Hour Interval     Total  
Number of Participants  
[units: participants]
 		  11     6     17  
Age  
[units: participants]
 		     
<=18 years     11     6     17  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     7     2     9  
Male     4     4     8  
Region of Enrollment  
[units: participants]
 		     
United States     11     6     17  
Gestational Age  
[units: weeks]
Mean ± Standard Deviation 		  29.8  ± 1.40     30.7  ± 0.99     30.1  ± 1.31  



  Outcome Measures
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1.  Primary:   Number of Participants With Respiratory Distress Syndrome   [ Time Frame: 24 hours ]
  Show Outcome Measure 1

2.  Secondary:   Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)   [ Time Frame: 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours ]
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3.  Secondary:   Arterial Alveolar (a/A) O₂Ratio   [ Time Frame: 72 hours ]
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4.  Secondary:   Time to Meet Failure Criteria   [ Time Frame: Through 28 days ]
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5.  Secondary:   Number of Participants With Bronchopulmonary Dysplasia (BPD)   [ Time Frame: 28 days ]
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6.  Secondary:   Number of Participants Alive and Without BPD   [ Time Frame: 28 days ]
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7.  Secondary:   Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)   [ Time Frame: 28 days ]
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8.  Secondary:   Number of Participants With Patent Ductus Arteriosus (PDA)   [ Time Frame: 28 days ]
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9.  Secondary:   Number of Participants With Necrotizing Enterocolitis (NEC)   [ Time Frame: 28 days ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With Pulmonary Hemorrhage   [ Time Frame: 28 days ]
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11.  Secondary:   Number of Participants With Acquired Sepsis   [ Time Frame: 28 days ]
  Show Outcome Measure 11

12.  Secondary:   Incidence of Mortality   [ Time Frame: 28 days ]
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13.  Secondary:   Number of Participants With Air Leak   [ Time Frame: 28 days ]
  Show Outcome Measure 13


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Robert Segal, MD
Organization: Discovery Laboratories, Inc.
phone: 215-488-9300
e-mail: rsegal@discoverylabs.com


Publications of Results:


Responsible Party: Discovery Laboratories
ClinicalTrials.gov Identifier: NCT00807235     History of Changes
Other Study ID Numbers: KL4-CPAP-01
Study First Received: December 10, 2008
Results First Received: April 2, 2012
Last Updated: May 11, 2012
Health Authority: United States: Food and Drug Administration