Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old (KL4-AHRF-01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00578734
First received: December 19, 2007
Last updated: May 1, 2012
Last verified: May 2012
Results First Received: April 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Hypoxemic Respiratory Failure
Interventions: Drug: Lucinactant
Other: Sham Comparator

  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
Subjects were enrolled at 24 hospitals in the United States and Chile from 04 June, 2007 to 23 March, 2010. Last subject's last visit occurred on 05 April, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lucinactant KL₄Surfactant (lucinactant) endotracheal instillation
Sham Air Sham air (placebo) instillation

Participant Flow:   Overall Study
    Lucinactant     Sham Air  
STARTED     84     81  
COMPLETED     84     81  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Lucinactant KL₄Surfactant (lucinactant) endotracheal instillation
Sham Air Sham air (placebo) instillation
Total Total of all reporting groups

Baseline Measures
    Lucinactant     Sham Air     Total  
Number of Participants  
[units: participants]
  84     81     165  
Age  
[units: participants]
     
<=18 years     84     81     165  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  0.44  ± 0.43     0.45  ± 0.43     0.45  ± 0.43  
Gender  
[units: participants]
     
Female     29     27     56  
Male     55     54     109  
Region of Enrollment  
[units: participants]
     
United States     28     27     55  
Chile     56     54     110  



  Outcome Measures
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1.  Primary:   Duration of Mechanical Ventilation Through 14 Days   [ Time Frame: Up to 14 Days ]

2.  Secondary:   Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days   [ Time Frame: Up to 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Neal J. Thomas
Organization: Penn State Children's Hospital
phone: 717-531-5337
e-mail: nthomas@hmc.psu.edu


No publications provided by Discovery Laboratories, Inc.

Publications automatically indexed to this study:

Responsible Party: Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00578734     History of Changes
Other Study ID Numbers: KL4-AHRF-01
Study First Received: December 19, 2007
Results First Received: April 2, 2012
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile