NCT01471431

Extubation Readiness Study in Very Low Birthweight Infants

A Randomized Trial of the Spontaneous Breathing Trial to Extubate Very Low Birthweight Infants

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 48 Hours – 14 Weeks
• Healthy volunteers: Not accepted

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).

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
OTHER	spontaneous 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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2011-11-16
• Last updated: 2016-06-07

Locations

2 sites across 1 country: United States