NCT01531010

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

Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

Summary

Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. This study aims to compare pressure-limited to VTV in preterm infants. Hypothesis: Volume-targeted will be associated with more rapid achievement of weaning criteria compared to pressure-limited ventilation Primary outcome: Time taken to achieve pre-specified weaning criteria. Methods: Ventilated infants less than 34 weeks gestational age at birth were recruited within the first 24 hours of life 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, required peak pressures of more than 26 cm of water or developed pulmonary haemorrhage. Analysis will be by intention-to-treat.

Conditions

• Neonatal Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Ventilation protocol delivered by the SLE5000 ventilator	In pressure-limited ventilation arm, preferentially wean pressure till weaning criteria achieved, then wean rate. 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: 2010-07-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-02-10
• Last updated: 2012-02-10

Locations

1 site across 1 country: United Kingdom