Trial Outcomes & Findings for A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation (NCT NCT03292562)
NCT ID: NCT03292562
Last Updated: 2020-03-17
Results Overview
Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
from randomization until 28 days post-randomization
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
Discontinue NCPAP After Weaning Pressures
After randomization, continuous positive airway pressure (CPAP) will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter (1L) flow, 30% FiO2).
|
Discontinue NCPAP Without Weaning Pressures
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter (1L) flow, 30% FiO2).
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Discontinue NCPAP After Weaning Pressures
n=35 Participants
After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.
|
Discontinue NCPAP Without Weaning Pressures
n=31 Participants
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 weeks
n=35 Participants
|
31.1 weeks
n=31 Participants
|
31.3 weeks
n=66 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
39 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=35 Participants
|
12 Participants
n=31 Participants
|
27 Participants
n=66 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
35 Participants
n=35 Participants
|
31 Participants
n=31 Participants
|
66 Participants
n=66 Participants
|
PRIMARY outcome
Timeframe: from randomization until 28 days post-randomizationSubjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Outcome measures
| Measure |
Discontinue NCPAP After Weaning Pressures
n=35 Participants
After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.
|
Discontinue NCPAP Without Weaning Pressures
n=31 Participants
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
|
|---|---|---|
|
Number of Days on NCPAP or Mechanical Ventilation
|
17.3 days
Interval 14.2 to 20.4
|
12.3 days
Interval 8.9 to 15.6
|
SECONDARY outcome
Timeframe: from randomization until 28 days post-randomizationPopulation: Data for this measure was not collected.
Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from randomization until discharge (about 92 days)Outcome measures
| Measure |
Discontinue NCPAP After Weaning Pressures
n=35 Participants
After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.
|
Discontinue NCPAP Without Weaning Pressures
n=31 Participants
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
|
|---|---|---|
|
Number of Participants Who Failed to Wean Off NCPAP
|
13 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: from randomization until discharge (about 92 days)Outcome measures
| Measure |
Discontinue NCPAP After Weaning Pressures
n=35 Participants
After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.
|
Discontinue NCPAP Without Weaning Pressures
n=31 Participants
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
|
|---|---|---|
|
Number of Participants Who Developed Bronchopulmonary Dysplasia
|
18 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: from randomization until discharge (about 92 days)Outcome measures
| Measure |
Discontinue NCPAP After Weaning Pressures
n=35 Participants
After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.
|
Discontinue NCPAP Without Weaning Pressures
n=31 Participants
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
|
|---|---|---|
|
Number of Participants Who Developed Necrotizing Enterocolitis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from randomization until discharge (about 92 days)Outcome measures
| Measure |
Discontinue NCPAP After Weaning Pressures
n=35 Participants
After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.
|
Discontinue NCPAP Without Weaning Pressures
n=31 Participants
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
|
|---|---|---|
|
Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth
|
78 number of days of life
Interval 69.0 to 88.0
|
73 number of days of life
Interval 64.0 to 82.0
|
SECONDARY outcome
Timeframe: from admission to hospital until discharge (about 92 days)Outcome measures
| Measure |
Discontinue NCPAP After Weaning Pressures
n=35 Participants
After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.
|
Discontinue NCPAP Without Weaning Pressures
n=31 Participants
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
|
|---|---|---|
|
Length of Hospital Stay
|
91.2 days
Interval 80.0 to 102.4
|
93.3 days
Interval 77.8 to 108.7
|
SECONDARY outcome
Timeframe: from randomization until discharge (about 92 days)Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.
Outcome measures
| Measure |
Discontinue NCPAP After Weaning Pressures
n=35 Participants
After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.
|
Discontinue NCPAP Without Weaning Pressures
n=31 Participants
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
|
|---|---|---|
|
Number of Participants Who Developed Air Leak Disorders
|
0 Participants
|
0 Participants
|
Adverse Events
Discontinue NCPAP After Weaning Pressures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Discontinue NCPAP Without Weaning Pressures
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
Amir Khan, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-5519
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place