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CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients (CALIPSO)

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ClinicalTrials.gov Identifier: NCT00999713
Recruitment Status : Completed
First Posted : October 22, 2009
Results First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Neal Thomas, Penn State University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Lung Injury
Interventions: Drug: Calfactant
Other: Air placebo

  Participant Flow

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
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Reporting Groups
  Description
Calfactant

Endotracheal calfactant administration

Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies

Placebo (Air)

Endotracheal air administration

Air placebo: Endotracheal air administration


Participant Flow:   Overall Study
    Calfactant   Placebo (Air)
STARTED   26   17 
COMPLETED   24   17 
NOT COMPLETED   2   0 
Physician Decision                2                0 



  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
Calfactant

Endotracheal calfactant administration

Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies

Placebo (Air)

Endotracheal air administration

Air placebo: Endotracheal air administration

Total Total of all reporting groups

Baseline Measures
   Calfactant   Placebo (Air)   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   17   43 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      23  88.5%      16  94.1%      39  90.7% 
Between 18 and 65 years      3  11.5%      1   5.9%      4   9.3% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  38.5%      5  29.4%      15  34.9% 
Male      16  61.5%      12  70.6%      28  65.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      7  26.9%      8  47.1%      15  34.9% 
Not Hispanic or Latino      15  57.7%      8  47.1%      23  53.5% 
Unknown or Not Reported      4  15.4%      1   5.9%      5  11.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   3.8%      0   0.0%      1   2.3% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5  19.2%      2  11.8%      7  16.3% 
White      16  61.5%      14  82.4%      30  69.8% 
More than one race      1   3.8%      0   0.0%      1   2.3% 
Unknown or Not Reported      3  11.5%      1   5.9%      4   9.3% 
Region of Enrollment 
[Units: Participants]
     
Canada   0   1   1 
United States   26   16   42 


  Outcome Measures

1.  Primary:   All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge   [ Time Frame: Admission to PICU discharge, up to 120 days ]

2.  Secondary:   Ventilator Free Days (VFDs)   [ Time Frame: 60 days after study enrollment ]

3.  Secondary:   Total Duration of Stay Required   [ Time Frame: Admission to discharge, up to 120 days ]

4.  Secondary:   Change in Oxygenation: First Intervention   [ Time Frame: 48 hours after enrollment, up to 12 hours after each intervention ]

5.  Secondary:   Change in Oxygenation: Second Intervention   [ Time Frame: 48 hours after enrollment, up to 12 hours after each intervention ]


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Neal J. Thomas, M.D.
Organization: Penn State College of Medicine
phone: 717-531-5337
e-mail: nthomas@psu.edu


Publications:

Responsible Party: Neal Thomas, Penn State University
ClinicalTrials.gov Identifier: NCT00999713     History of Changes
Other Study ID Numbers: 1R01FD003410-01 ( U.S. FDA Grant/Contract )
R01FD003410-01A1 ( U.S. FDA Grant/Contract )
First Submitted: October 18, 2009
First Posted: October 22, 2009
Results First Submitted: January 19, 2018
Results First Posted: March 16, 2018
Last Update Posted: March 16, 2018