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Trial Outcomes & Findings for Impact of CPAP Level on V/Q Mismatch in Premature Infants (NCT NCT02983825)

NCT ID: NCT02983825

Last Updated: 2021-03-25

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

variable; up to 2 hours

Results posted on

2021-03-25

Participant Flow

Participant milestones

Participant milestones
Measure
Continuous Positive Airway Pressure (CPAP) Level Changes
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 Study
STARTED
12
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Continuous Positive Airway Pressure (CPAP) Level Changes
n=12 Participants
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
Age, Continuous
19 days
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=5 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: variable; up to 2 hours

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

Outcome measures

Outcome measures
Measure
Continuous Positive Airway Pressure (CPAP) Level Changes
n=9 Participants
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
Ventilation/Perfusion Mismatch
1.2 difference in right shift (kPa)
Interval 0.0 to 3.2

SECONDARY outcome

Timeframe: variable, up to 2 hours

Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level

Outcome measures

Outcome measures
Measure
Continuous Positive Airway Pressure (CPAP) Level Changes
n=9 Participants
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
Best CPAP Level
7 cm H2O
Interval 7.0 to 8.0

Adverse Events

Continuous Positive Airway Pressure (CPAP) Level Changes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicolas Bamat, MD MSCE

University of Pennsylvania

Phone: 2155904010

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place