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Futility analysis by DSMC recommended termination.
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The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for >48 hours and have not yet been successfully extubated (extubated >7 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous breathing trial | Experimental | The spontaneous breathing trial will determine the extubation readiness of the subject. |
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| Usual care | No Intervention | Subjects will be extubated using usual care, without the use of the spontaneous breathing trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spontaneous breathing trial | Other | The SBT is performed daily on rounds if an infant is on conventional ventilation and meets all predetermined ventilator criteria (set ventilator rate ≤30, peak inspiratory pressure (PIP) delivered on mandatory breaths ≤20 cm H2O, pressure support (PS) ≤8 cm H2O, positive end-expiratory pressure (PEEP) ≤6 cm H2O, inspired fractional oxygen (FiO2) ≤0.40). During the SBT, the ventilator rate and pressure support are set to zero, and the infant is maintained on continuous positive airway pressure (CPAP) alone via the endotracheal tube. The trial duration is 3 minutes, unless an infant fails before the trial is complete. Failure is defined as bradycardia <100 for >15 seconds or oxygen saturation by pulse oximetry <85% despite a 15% increase in FiO2. If an infant passes the SBT, they are extubated within 3 hours. If an infant fails the SBT, they remain intubated and the daily application of the SBT continues as long as the minimum ventilator criteria are met. |
| Measure | Description | Time Frame |
|---|---|---|
| time to successful extubation | The time from intubation (if >48 hours) to successful extubation (if > 7 days) as evaluated at 34 weeks postmenstrual age (gestational age + chronologic age) | 34 weeks postmenstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| bronchopulmonary dysplasia | The diagnosis of bronchopulmonary dysplasia will be made at 36 weeks postmenstrual age, using the traditional definition and the NIH Consensus definition. | 36 weeks postmenstrual age |
| extubation failure rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann-Johanna Giaccone, MD | University of Pennsylvania | Study Director |
| Barbara Schmidt, MD, MSc | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital of the University of Pennsylvania | Phialdelphia | Pennsylvania | 19104 | United States | ||
| Pennsylvania Hospital |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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The proportion of infants who fail extubation will be compared between the 2 groups.
| 34 weeks postmenstrual age |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |