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Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome

This study has been terminated.
(Slow enrollment and administrative reasons)
Sponsor:
Information provided by (Responsible Party):
Discovery Laboratories
ClinicalTrials.gov Identifier:
NCT00004500
First received: October 18, 1999
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
Results First Received: April 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Meconium Aspiration
Interventions: Drug: Lucinactant
Other: Standard Care

  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
Recruitment occurred between March 2000 and October 2002. Infants were enrolled from neonatal intensive care units and were randomized to open-label study treatment.

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 Lucinactant via bronchoaveolar lavage
Standard Care Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization

Participant Flow:   Overall Study
    Lucinactant     Standard Care  
STARTED     38     31  
1 Year Follow-Up     24     24  
COMPLETED     38     31  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Lucinactant Lucinactant via bronchoaveolar lavage
Standard Care Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Total Total of all reporting groups

Baseline Measures
    Lucinactant     Standard Care     Total  
Number of Participants  
[units: participants]
 		  38     31     69  
Age  
[units: participants]
 		     
<=18 years     38     31     69  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     16     15     31  
Male     22     16     38  
Region of Enrollment  
[units: participants]
 		     
United States     38     31     69  
Gestational Age  
[units: weeks]
Mean ± Standard Deviation 		  40.0  ± 1.30     39.7  ± 1.09     39.9  ± 1.21  



  Outcome Measures
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1.  Primary:   Number of Days Receiving Mechanical Ventilation (MV)   [ Time Frame: 28 days ]
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2.  Secondary:   Incidence of Death   [ Time Frame: 28 days ]
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3.  Secondary:   Number of Participants With Air Leaks   [ Time Frame: 28 days ]
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Measure Type Secondary
Measure Title Number of Participants With Air Leaks
Measure Description Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium
Time Frame 28 days  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.

All enrolled infants were analyzed (intent-to-treat).

Reporting Groups
  Description
Lucinactant Lucinactant via bronchoaveolar lavage
Standard Care Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization

Measured Values
    Lucinactant     Standard Care  
Number of Participants Analyzed  
[units: participants]
 		  38     31  
Number of Participants With Air Leaks  
[units: participants]
 		  2     0  

No statistical analysis provided for Number of Participants With Air Leaks




  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
Early termination led to a small number of subjects analyzed. Results should be interpreted with caution.  


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


No publications provided


Responsible Party: Discovery Laboratories
ClinicalTrials.gov Identifier: NCT00004500     History of Changes
Other Study ID Numbers: KL4-MAS-03, FD-R-001938
Study First Received: October 18, 1999
Results First Received: April 2, 2012
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration