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Impact of CPAP Level on V/Q Mismatch in Premature Infants

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ClinicalTrials.gov Identifier: NCT02983825
Recruitment Status : Completed
First Posted : December 6, 2016
Results First Posted : July 30, 2020
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Infant, Premature, Diseases
Respiratory Insufficiency Syndrome of Newborn
Intervention Device: Continuous positive airway pressure (CPAP); level changes
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Continuous Positive Airway Pressure (CPAP) Level Changes
Hide Arm/Group Description

Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline

Continuous positive airway pressure (CPAP); level changes: as per arm description

Period Title: Overall Study
Started 12 [1]
Completed 9 [2]
Not Completed 3
[1]
Of 21 enrolled subjects, 9 became ineligible for between consent and intervention
[2]
Of 12 subjects starting intervention, 3 met specified stopping critieria
Arm/Group Title Continuous Positive Airway Pressure (CPAP) Level Changes
Hide Arm/Group Description

Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline

Continuous positive airway pressure (CPAP); level changes: as per arm description

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 12 participants
19
(16 to 39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
12
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  83.3%
White
2
  16.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Ventilation/Perfusion Mismatch
Hide Description Measured by non-invasive computerized technique based on curvilinear characteristics generated by a best-fit curve connecting the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs; measured as difference in degree of right-shift between baseline and "best" CPAP
Time Frame variable; up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Positive Airway Pressure (CPAP) Level Changes
Hide Arm/Group Description:

Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline

Continuous positive airway pressure (CPAP); level changes: as per arm description

Overall Number of Participants Analyzed 9
Median (Inter-Quartile Range)
Unit of Measure: difference in right shift (kPa)
1.2
(0 to 3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Positive Airway Pressure (CPAP) Level Changes
Comments Within subject repeat analysis; V/Q mismatch (measured as degree of right shift in kPa) baseline vs "best" CPAP
Type of Statistical Test Superiority
Comments Wilcoxon signed-rank test for nonparametric matched-pairs
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
2.Secondary Outcome
Title Best CPAP Level
Hide Description Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level
Time Frame variable, up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Positive Airway Pressure (CPAP) Level Changes
Hide Arm/Group Description:

Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline

Continuous positive airway pressure (CPAP); level changes: as per arm description

Overall Number of Participants Analyzed 9
Median (Inter-Quartile Range)
Unit of Measure: cm H2O
7
(7 to 8)
Time Frame 48 hours after intervention
Adverse Event Reporting Description Adverse event monitoring limited to air leak syndromes (pneumothorax, pulmonary interstitial emphysema, pneumomediastinum; as determined by the clinical supervising physician during routine clinical care) and respiratory deterioration, defined as an increase in baseline FiO2 greater than 0.10 in the 48 hour following the study intervention,
 
Arm/Group Title Continuous Positive Airway Pressure (CPAP) Level Changes
Hide Arm/Group Description

Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline

Continuous positive airway pressure (CPAP); level changes: as per arm description

All-Cause Mortality
Continuous Positive Airway Pressure (CPAP) Level Changes
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Serious Adverse Events
Continuous Positive Airway Pressure (CPAP) Level Changes
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Positive Airway Pressure (CPAP) Level Changes
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicolas Bamat, MD MSCE
Organization: University of Pennsylvania
Phone: 2155904010
EMail: bamatn@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02983825    
Other Study ID Numbers: 17-013910
825874 ( Other Identifier: University of Pennsylvania )
First Submitted: November 21, 2016
First Posted: December 6, 2016
Results First Submitted: July 9, 2020
Results First Posted: July 30, 2020
Last Update Posted: March 25, 2021