Respiratory Distress Syndrome
Conditions
Brief summary
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).
Interventions
OTHERspontaneous breathing trial
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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
48 Hours to 14 Weeks
Healthy volunteers
No
Inclusion criteria
* Birthweight \>500g and\<1500g. * Postmenstrual age \<34 weeks * Mechanically ventilated \>48 hours * Never successfully extubated
Exclusion criteria
* Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD) * Known or suspected airway anomalies * Severe congenital malformations * Need to remain intubated for other reasons (i.e. having surgery) * Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to successful extubation | 34 weeks postmenstrual age | The time from intubation (if \>48 hours) to successful extubation (if \> 7 days) as evaluated at 34 weeks postmenstrual age (gestational age + chronologic age) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bronchopulmonary dysplasia | 36 weeks postmenstrual age | The diagnosis of bronchopulmonary dysplasia will be made at 36 weeks postmenstrual age, using the traditional definition and the NIH Consensus definition. |
| extubation failure rate | 34 weeks postmenstrual age | The proportion of infants who fail extubation will be compared between the 2 groups. |
Countries
United States
Outcome results
None listed