NCT02358460

Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns

Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 1 Minute – 4 Weeks
• Healthy volunteers: Not accepted

Summary

A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.

Detailed description

Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants. Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.

Conditions

• Respiratory Insufficiency

Interventions

Type	Name	Description
DEVICE	Ventilation delivered by SLE5000 ventilator	In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination. In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits.

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2015-02-09
• Last updated: 2015-02-09

Locations

2 sites across 1 country: United Kingdom