Trial Outcomes & Findings for Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants (NCT NCT02249143)

Results Overview

Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation \<10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).

Results posted on

2019-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	CPAP and Room Air Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Overall Study STARTED	24	26
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator: CPAP and Room Air n=22 Participants CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	No Intervention: Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	8 Participants n=4 Participants	21 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	14 Participants n=4 Participants	23 Participants n=27 Participants
Region of Enrollment United States	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants

PRIMARY outcome

Timeframe: Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).

Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation \<10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=22 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants FRC change from baseline to two weeks	12.6 mL Standard Deviation 11.4	6.4 mL Standard Deviation 10.1
Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants FRC change from baseline to discharge	27.2 mL Standard Deviation 12.5	17.1 mL Standard Deviation 11.7

SECONDARY outcome

Timeframe: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age

Measurements of passive respiratory compliance will be done with the single breath occlusion technique.

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=22 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Measurements of Passive Respiratory Compliance in Randomized Premature Infants At Randomization	1.37 mL/Kg Standard Deviation 0.28	1.32 mL/Kg Standard Deviation 0.28
Measurements of Passive Respiratory Compliance in Randomized Premature Infants At End of 2 Weeks of Treatment	1.28 mL/Kg Standard Deviation 0.28	1.17 mL/Kg Standard Deviation 0.18
Measurements of Passive Respiratory Compliance in Randomized Premature Infants At Discharge	1.08 mL/Kg Standard Deviation 0.18	1.12 mL/Kg Standard Deviation 0.21

SECONDARY outcome

Timeframe: Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.

Measurements of passive respiratory resistance will be done with the single breath occlusion technique.

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=22 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Passive Respiratory Resistance in Randomized Premature Infants At Randomization	0.054 cmH2O/mL/sec Standard Deviation 0.014	0.053 cmH2O/mL/sec Standard Deviation 0.009
Passive Respiratory Resistance in Randomized Premature Infants At End of 2 Weeks of Treatment	0.061 cmH2O/mL/sec Standard Deviation 0.014	0.074 cmH2O/mL/sec Standard Deviation 0.021
Passive Respiratory Resistance in Randomized Premature Infants At Discharge	0.073 cmH2O/mL/sec Standard Deviation 0.02	0.082 cmH2O/mL/sec Standard Deviation 0.022

SECONDARY outcome

Timeframe: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.

Characteristics of tidal flow volume loops will be measured.

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=22 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants. At Randomization	7.1 mL Standard Deviation 1.1	7.8 mL Standard Deviation 0.97
Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants. At End of 2 Weeks of Treatment	7.6 mL Standard Deviation 1.1	7.4 mL Standard Deviation 0.9
Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants. At Discharge	7.3 mL Standard Deviation 1.1	7.3 mL Standard Deviation 0.56

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization through discharge at about 35-37 weeks of corrected gestational age.

Changes in growth parameters will be compared between randomized groups.

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=22 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Changes in the Growth Parameters Between the Randomized Premature Infants At Randomization	1567 g Standard Deviation 293	1482 g Standard Deviation 323
Changes in the Growth Parameters Between the Randomized Premature Infants At Discharge	2282 g Standard Deviation 354	2253 g Standard Deviation 413

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).

Adverse events and serious adverse events occurring in the randomized groups will be documented carefully

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=22 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization through discharge at about 35-37 weeks of corrected gestational age.

The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=22 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Corrected Gestational Age at Which Full Nipple Feeds Are Achieved	35.9 weeks Interval 35.1 to 37.5	35.5 weeks Interval 34.7 to 37.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge through one year of corrected age

Population: Number of participants analyzed is lower here as we were not able to follow all infants through 1 year of corrected age.

Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=18 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=21 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Incidence of Wheezing Through One Year of Age	7 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 12 months of corrected age

Population: Data not collected

Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through discharge at about 35-37 weeks of corrected gestational age

The days of oxygen supplementation will be compared between the groups of randomized patients.

Outcome measures

Outcome measures
Measure	CPAP and Room Air n=22 Participants Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.	Room Air n=22 Participants Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Days on Oxygen Between the Randomized Groups	0 days Interval 0.0 to 2.3	0 days Interval 0.0 to 4.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Delivery through discharge at about 35-37 weeks of corrected gestational age

Population: Data not collected

The days in the hospital will be compared between the randomized groups.

Outcome measures

Outcome data not reported

Adverse Events

CPAP and Room Air

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Room Air

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

Cindy McEvoy, MD

OHSU

Phone: 503-494-0223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place