SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.

This study has been terminated.
(Concerns related to availability of drug product)
Sponsor:
Information provided by (Responsible Party):
Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00215540
First received: September 14, 2005
Last updated: May 11, 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, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Respiratory Distress Syndrome, Newborn
Premature Birth
Bronchopulmonary Dysplasia
Interventions: Drug: Lucinactant 175 mg/kg
Drug: Lucinactant 90 mg/kg
Drug: Placebo

  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
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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
SURFAXIN High Dose SURFAXIN (lucinactant) at 175 mg/kg
SURFAXIN Low Dose SURFAXIN (lucinactant) at 90 mg/kg
Placebo Sham air using 3.0 mL/kg volume of air

Participant Flow:   Overall Study
    SURFAXIN High Dose     SURFAXIN Low Dose     Placebo  
STARTED     45     47     44  
COMPLETED     44     47     44  
NOT COMPLETED     1     0     0  
Withdrew from study medication                 1                 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
SURFAXIN High Dose SURFAXIN (lucinactant) at 175 mg/kg
SURFAXIN Low Dose SURFAXIN (lucinactant) at 90 mg/kg
Placebo Sham air using 3.0 mL/kg volume of air
Total Total of all reporting groups

Baseline Measures
    SURFAXIN High Dose     SURFAXIN Low Dose     Placebo     Total  
Number of Participants  
[units: participants]
  45     47     44     136  
Age  
[units: participants]
       
<=18 years     45     47     44     136  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     21     17     27     65  
Male     24     30     17     71  
Region of Enrollment  
[units: participants]
       
United States     17     20     19     56  
Chile     8     10     7     25  
Poland     17     14     16     47  
Hungary     3     3     2     8  
Gestational Age  
[units: weeks]
Mean ± Standard Deviation
  26.1  ± 1.68     25.5  ± 1.43     25.7  ± 1.36     25.8  ± 1.49  



  Outcome Measures
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1.  Primary:   Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks   [ Time Frame: 36 weeks post-menstrual age (PMA) ]

2.  Primary:   All-cause Mortality   [ Time Frame: 36 weeks PMA ]

3.  Secondary:   BPD at 28 Days   [ Time Frame: 28 days of life ]

4.  Secondary:   BPD at 36 Weeks   [ Time Frame: 36 weeks PMA ]

5.  Secondary:   Days Receiving Mechanical Ventilation (MV)   [ Time Frame: 36 weeks PMA ]

6.  Secondary:   Duration of Supplemental Oxygen   [ Time Frame: 36 weeks PMA ]

7.  Secondary:   Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)   [ Time Frame: 15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28 ]

8.  Secondary:   Area Under the Curve for Mean Arterial Pressure (MAP)   [ Time Frame: 15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28 ]

9.  Secondary:   Incidence of Death or BPD at 28 Days   [ Time Frame: 28 days of life ]

10.  Secondary:   Days in Hospital   [ Time Frame: 36 weeks PMA ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


Publications of Results:

Responsible Party: Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00215540     History of Changes
Other Study ID Numbers: KL4-BPD-01
Study First Received: September 14, 2005
Results First Received: April 2, 2012
Last Updated: May 11, 2012
Health Authority: United States: Food and Drug Administration