Apnea of Prematurity
Conditions
Brief summary
The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).
Interventions
DEVICENCPAP 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.
DEVICENIPPV 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Infants born at \< 30 weeks gestational age who develop clinically significant apnea while on NCPAP \> 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour. * Infants on maximum caffeine therapy (10mg/kg/day)
Exclusion criteria
\- Major congenital anomalies including congenital heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Were Intubated | 28 days after randomization |
| Duration of Intubation | 28 days after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Necrotizing Enterocolitis (NEC) | 36 weeks corrected gestational age | — |
| Number of Participants With Air Leak Disorders | 36 weeks corrected gestational age | Air leak disorders include pneumothorax and/or pneumomediastinum. |
| Number of Apneic Events | 28 days after randomization | — |
| Length of Hospital Stay | about 10 to 18 weeks | — |
| Number of Participants Who Died | until discharge (about 10 to 18 weeks) or death | — |
| Weight Gain | 36 weeks corrected gestational age | — |
| Number of Participants With Bronchopulmonary Dysplasia (BPD) | 36 weeks corrected gestational age | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 9 |
| Total | 19 |
Baseline characteristics
| Characteristic | Total | NIPPV as Rescue Mode for Apnea Prevention | NCPAP as Mode for Apnea Prevention |
|---|---|---|---|
| Age, Continuous | 25.8 weeks STANDARD_DEVIATION 1.6 | 25.8 weeks STANDARD_DEVIATION 0.8 | 25.8 weeks STANDARD_DEVIATION 2.2 |
| Birth Weight | 835 grams STANDARD_DEVIATION 313.3 | 773 grams STANDARD_DEVIATION 160.5 | 858 grams STANDARD_DEVIATION 293.4 |
| Corrected Gestational Age | 28.4 weeks STANDARD_DEVIATION 2 | 28.4 weeks STANDARD_DEVIATION 2.5 | 28.4 weeks STANDARD_DEVIATION 1.1 |
| Number of Participants Who Received Surfactant | 13 Participants | 7 Participants | 6 Participants |
| Number of Participants with Antenatal Glucocorticoid Exposure | 8 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized African American | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Causcasian | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 19 Participants | 10 Participants | 9 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 7 Participants |
| Weight at Enrollment | 920.6 grams STANDARD_DEVIATION 236.7 | 920 grams STANDARD_DEVIATION 286.6 | 921 grams STANDARD_DEVIATION 204.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
Primary
Duration of Intubation
Time frame: 28 days after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NIPPV as Rescue Mode for Apnea Prevention | Duration of Intubation | 10.6 days | Standard Deviation 10.2 |
| NCPAP as Mode for Apnea Prevention | Duration of Intubation | 17.5 days | Standard Deviation 11.4 |
Primary
Number of Participants Who Were Intubated
Time frame: 28 days after randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIPPV as Rescue Mode for Apnea Prevention | Number of Participants Who Were Intubated | 6 Participants |
| NCPAP as Mode for Apnea Prevention | Number of Participants Who Were Intubated | 8 Participants |
Secondary
Length of Hospital Stay
Time frame: about 10 to 18 weeks
Population: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NIPPV as Rescue Mode for Apnea Prevention | Length of Hospital Stay | 136 days | Standard Deviation 57.7 |
| NCPAP as Mode for Apnea Prevention | Length of Hospital Stay | 149 days | Standard Deviation 67.1 |
Secondary
Number of Apneic Events
Time frame: 28 days after randomization
Population: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NIPPV as Rescue Mode for Apnea Prevention | Number of Apneic Events | 3.78 Number of apneic events | Standard Deviation 3.42 |
| NCPAP as Mode for Apnea Prevention | Number of Apneic Events | 6.22 Number of apneic events | Standard Deviation 5.52 |
Secondary
Number of Participants Who Died
Time frame: until discharge (about 10 to 18 weeks) or death
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIPPV as Rescue Mode for Apnea Prevention | Number of Participants Who Died | 1 Participants |
| NCPAP as Mode for Apnea Prevention | Number of Participants Who Died | 0 Participants |
Secondary
Number of Participants With Air Leak Disorders
Air leak disorders include pneumothorax and/or pneumomediastinum.
Time frame: 36 weeks corrected gestational age
Population: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIPPV as Rescue Mode for Apnea Prevention | Number of Participants With Air Leak Disorders | 0 Participants |
| NCPAP as Mode for Apnea Prevention | Number of Participants With Air Leak Disorders | 0 Participants |
Secondary
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time frame: 36 weeks corrected gestational age
Population: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIPPV as Rescue Mode for Apnea Prevention | Number of Participants With Bronchopulmonary Dysplasia (BPD) | 9 Participants |
| NCPAP as Mode for Apnea Prevention | Number of Participants With Bronchopulmonary Dysplasia (BPD) | 8 Participants |
Secondary
Number of Participants With Necrotizing Enterocolitis (NEC)
Time frame: 36 weeks corrected gestational age
Population: One participant in the NIPPV group died; therefore, this data was not collected for that participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIPPV as Rescue Mode for Apnea Prevention | Number of Participants With Necrotizing Enterocolitis (NEC) | 1 Participants |
| NCPAP as Mode for Apnea Prevention | Number of Participants With Necrotizing Enterocolitis (NEC) | 5 Participants |
Secondary
Weight Gain
Time frame: 36 weeks corrected gestational age
Population: Data were not collected for this outcome measure.