Trial Outcomes & Findings for A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants (NCT NCT03298035)
NCT ID: NCT03298035
Last Updated: 2020-02-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
28 days after randomization
Results posted on
2020-02-07
Participant Flow
Participant milestones
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
Received Intervention
|
9
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
Baseline characteristics by cohort
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=10 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.8 weeks
STANDARD_DEVIATION 0.8 • n=5 Participants
|
25.8 weeks
STANDARD_DEVIATION 2.2 • n=7 Participants
|
25.8 weeks
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Causcasian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Birth Weight
|
773 grams
STANDARD_DEVIATION 160.5 • n=5 Participants
|
858 grams
STANDARD_DEVIATION 293.4 • n=7 Participants
|
835 grams
STANDARD_DEVIATION 313.3 • n=5 Participants
|
|
Weight at Enrollment
|
920 grams
STANDARD_DEVIATION 286.6 • n=5 Participants
|
921 grams
STANDARD_DEVIATION 204.4 • n=7 Participants
|
920.6 grams
STANDARD_DEVIATION 236.7 • n=5 Participants
|
|
Corrected Gestational Age
|
28.4 weeks
STANDARD_DEVIATION 2.5 • n=5 Participants
|
28.4 weeks
STANDARD_DEVIATION 1.1 • n=7 Participants
|
28.4 weeks
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Number of Participants with Antenatal Glucocorticoid Exposure
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of Participants Who Received Surfactant
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after randomizationOutcome measures
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=10 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Number of Participants Who Were Intubated
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 28 days after randomizationOutcome measures
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=10 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Duration of Intubation
|
10.6 days
Standard Deviation 10.2
|
17.5 days
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 28 days after randomizationPopulation: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
Outcome measures
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Number of Apneic Events
|
3.78 Number of apneic events
Standard Deviation 3.42
|
6.22 Number of apneic events
Standard Deviation 5.52
|
SECONDARY outcome
Timeframe: 36 weeks corrected gestational agePopulation: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
Outcome measures
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 36 weeks corrected gestational agePopulation: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
Outcome measures
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Number of Participants With Necrotizing Enterocolitis (NEC)
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 36 weeks corrected gestational agePopulation: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
Air leak disorders include pneumothorax and/or pneumomediastinum.
Outcome measures
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Number of Participants With Air Leak Disorders
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 36 weeks corrected gestational agePopulation: Data were not collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: about 10 to 18 weeksPopulation: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
Outcome measures
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Length of Hospital Stay
|
136 days
Standard Deviation 57.7
|
149 days
Standard Deviation 67.1
|
SECONDARY outcome
Timeframe: until discharge (about 10 to 18 weeks) or deathOutcome measures
| Measure |
NIPPV as Rescue Mode for Apnea Prevention
n=10 Participants
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
|
NCPAP as Mode for Apnea Prevention
n=9 Participants
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
|
|---|---|---|
|
Number of Participants Who Died
|
1 Participants
|
0 Participants
|
Adverse Events
NIPPV as Rescue Mode for Apnea Prevention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
NCPAP as Mode for Apnea Prevention
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
Catherine C. Beaullieu, MD
The University of Texas Health Science Center at Houston
Phone: (713) 500-6044
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place