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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
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calfactant Placebo (Air)
Hide Arm/Group Description

Endotracheal calfactant administration

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

Endotracheal air administration

Air placebo: Endotracheal air administration

Period Title: Overall Study
Started 26 17
Completed 24 17
Not Completed 2 0
Reason Not Completed
Physician Decision             2             0
Arm/Group Title Calfactant Placebo (Air) Total
Hide Arm/Group Description

Endotracheal calfactant administration

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

Endotracheal air administration

Air placebo: Endotracheal air administration

Total of all reporting groups
Overall Number of Baseline Participants 26 17 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 17 participants 43 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 17 participants 43 participants
Female
10
  38.5%
5
  29.4%
15
  34.9%
Male
16
  61.5%
12
  70.6%
28
  65.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 17 participants 43 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 17 participants 43 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 17 participants 43 participants
Canada 0 1 1
United States 26 16 42
1.Primary Outcome
Title All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge
Hide Description Overall mortality rate from admission to PICU discharge
Time Frame Admission to PICU discharge, up to 120 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calfactant Placebo (Air)
Hide Arm/Group Description:

Endotracheal calfactant administration

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

Endotracheal air administration

Air placebo: Endotracheal air administration

Overall Number of Participants Analyzed 26 17
Measure Type: Count of Participants
Unit of Measure: Participants
15
  57.7%
6
  35.3%
2.Secondary Outcome
Title Ventilator Free Days (VFDs)
Hide Description Number of days the patient is alive and off of the ventilator
Time Frame 60 days after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calfactant Placebo (Air)
Hide Arm/Group Description:

Endotracheal calfactant administration

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

Endotracheal air administration

Air placebo: Endotracheal air administration

Overall Number of Participants Analyzed 26 17
Median (Inter-Quartile Range)
Unit of Measure: Days
0
(0 to 21.02)
5.40
(0 to 17.44)
3.Secondary Outcome
Title Total Duration of Stay Required
Hide Description Length of stay (LOS) ,measured in days, from admission to PICU discharge and admission to hospital discharge.
Time Frame Admission to discharge, up to 120 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calfactant Placebo (Air)
Hide Arm/Group Description:

Endotracheal calfactant administration

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

Endotracheal air administration

Air placebo: Endotracheal air administration

Overall Number of Participants Analyzed 26 17
Median (Inter-Quartile Range)
Unit of Measure: days
LOS from admission to PICU discharge
15.5
(8 to 29.5)
21
(12.5 to 39.5)
LOS from admission to hospital discharge
34.5
(17.5 to 95.5)
65
(21 to 107.5)
4.Secondary Outcome
Title Change in Oxygenation: First Intervention
Hide Description The Oxygenation Index after the first intervention is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.
Time Frame 48 hours after enrollment, up to 12 hours after each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of subjects analyzed at each measurement fluctuates due to arterial blood gas testing not being ordered at the appropriate time (i.e., subjects missing a test at a specific time point since the frequency of these tests in this study are not standard of care).
Arm/Group Title Calfactant Placebo (Air)
Hide Arm/Group Description:

Endotracheal calfactant administration

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

Endotracheal air administration

Air placebo: Endotracheal air administration

Overall Number of Participants Analyzed 24 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: index number
First Intervention: Hour 0 Number Analyzed 22 participants 16 participants
18.30178397
(14.8899734 to 22.49535894)
20.59720208
(16.21205422 to 26.16847488)
First Intervention: Hour 1 Number Analyzed 22 participants 14 participants
16.10723481
(12.40927173 to 20.9071909)
19.25708144
(13.98618037 to 26.51440036)
First Intervention: Hour 4 Number Analyzed 22 participants 15 participants
14.79254257
(11.76126752 to 18.60507937)
16.80523147
(12.85367235 to 21.97160447)
First Intervention: Hour 12 Number Analyzed 22 participants 15 participants
17.06208571
(13.03988505 to 22.32494901)
16.42411116
(11.98559242 to 22.50630741)
5.Secondary Outcome
Title Change in Oxygenation: Second Intervention
Hide Description The Oxygenation Index after the second intervention (if applicable) is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.
Time Frame 48 hours after enrollment, up to 12 hours after each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of subjects analyzed at each measurement fluctuates due to arterial blood gas testing not being ordered at the appropriate time (i.e., subjects missing a test at a specific time point since the frequency of these tests in this study are not standard of care).
Arm/Group Title Calfactant Placebo (Air)
Hide Arm/Group Description:

Endotracheal calfactant administration

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

Endotracheal air administration

Air placebo: Endotracheal air administration

Overall Number of Participants Analyzed 16 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: index number
Second Intervention: Hour 0 Number Analyzed 14 participants 13 participants
15.65261779
(10.74981818 to 22.79149651)
15.05105738
(10.19615508 to 22.21762286)
Second Intervention: Hour 1 Number Analyzed 15 participants 12 participants
21.28116857
(15.40809906 to 29.39286242)
14.68059885
(10.36992308 to 20.78318046)
Second Intervention: Hour 4 Number Analyzed 15 participants 12 participants
17.47108142
(13.41337922 to 22.75628541)
15.40251337
(11.60739802 to 20.43846672)
Second Intervention: Hour 12 Number Analyzed 14 participants 12 participants
17.26865232
(12.65514101 to 23.56404822)
14.83842164
(10.66746181 to 20.64021983)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calfactant Placebo (Air)
Hide Arm/Group Description

Endotracheal calfactant administration

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

Endotracheal air administration

Air placebo: Endotracheal air administration

All-Cause Mortality
Calfactant Placebo (Air)
Affected / at Risk (%) Affected / at Risk (%)
Total   15/26 (57.69%)      7/17 (41.18%)    
Show Serious Adverse Events Hide Serious Adverse Events
Calfactant Placebo (Air)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/26 (57.69%)      7/17 (41.18%)    
Blood and lymphatic system disorders     
Death   15/26 (57.69%)  15 7/17 (41.18%)  7
Renal and urinary disorders     
Renal Failure   2/26 (7.69%)  2 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypoxia   4/26 (15.38%)  4 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calfactant Placebo (Air)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/26 (30.77%)      1/17 (5.88%)    
Respiratory, thoracic and mediastinal disorders     
Peri-dosing hypotension   3/26 (11.54%)  3 0/17 (0.00%)  0
Peri-dosing Hypoxia or Hypotension   4/26 (15.38%)  4 1/17 (5.88%)  1
Pneumomediatinum   1/26 (3.85%)  1 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Neal J. Thomas, M.D.
Organization: Penn State College of Medicine
Phone: 717-531-5337
EMail: nthomas@psu.edu
Layout table for additonal information
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