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

Neonatal Respiratory Failure Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01531010
Study type Interventional
Source King's College London
Contact
Status Completed
Phase N/A
Start date July 2010
Completion date February 2012
View Details
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