We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00215540
First Posted: September 22, 2005
Last Update Posted: June 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Windtree Therapeutics
Results First Submitted: April 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Hide Baseline Characteristics

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.
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
Total Total of all reporting groups

Baseline Measures
   SURFAXIN High Dose   SURFAXIN Low Dose   Placebo   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


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: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT00215540     History of Changes
Other Study ID Numbers: KL4-BPD-01
First Submitted: September 14, 2005
First Posted: September 22, 2005
Results First Submitted: April 2, 2012
Results First Posted: June 13, 2012
Last Update Posted: June 13, 2012