Bronchopulmonary Dysplasia
Conditions
Keywords
Respiration, Artificial, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure, Non-Invasive Positive-Pressure Ventilation, Intermittent Positive-Pressure Ventilation, High-Frequency Ventilation
Brief summary
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.
Interventions
PROCEDUREExtubation to NIPPV
After extubation infants were placed on NIPPV as soon as all the extubation criteria were met
PROCEDUREExtubation to CPAP
After extubation infants were placed on CPAP
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No
Inclusion criteria
* Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria. * Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life. * Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz. * Infants who have never been previously extubated.
Exclusion criteria
* Infants enrolled in competing trials. * Participation refused by parent/attending physician/ parent unavailable for consent. * Infants with any major congenital abnormality. * Postoperative patients from any surgery. * Infants in extremis/decided upon not to receive intensive care. * Ventilator settings lower than the intervention group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Days Being Intubated | 30 days from birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Reintubation | 0-7 days post-extubation | Reintubation rate is a measure of the efficacy of NIPPV. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NIPPV Extubation to NIPPV (nasal intermittent positive pressure ventilation) | 16 |
| CPAP After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life | 18 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 3 |
Baseline characteristics
| Characteristic | CPAP | NIPPV | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 16 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous Gestational age in weeks | 25.7 weeks STANDARD_DEVIATION 1.1 | 26.1 weeks STANDARD_DEVIATION 1.1 | 25.9 weeks STANDARD_DEVIATION 1.1 |
| Region of Enrollment United States | 18 participants | 16 participants | 34 participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 18 |
| serious Total, serious adverse events | 2 / 16 | 3 / 18 |
Outcome results
Primary
Number of Days Being Intubated
Time frame: 30 days from birth
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NIPPV | Number of Days Being Intubated | 12.4 days |
| CPAP | Number of Days Being Intubated | 6.2 days |
Secondary
Percentage of Participants With Reintubation
Reintubation rate is a measure of the efficacy of NIPPV.
Time frame: 0-7 days post-extubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NIPPV | Percentage of Participants With Reintubation | 67 % of participants with reintubation |
| CPAP | Percentage of Participants With Reintubation | 28 % of participants with reintubation |