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

Not Applicable

Completed

• Conditions: Respiratory Insufficiency
• Interventions: Device: Ventilation delivered by SLE5000 ventilator

• Registration Number: NCT02358460
• Lead Sponsor: King's College London

Brief 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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2015-01-13
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-03
• Last Update Submitted: 2015-02-03
• Study First Posted: 2015-02-09
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Mechanically ventilated
• Born at gestation 34 weeks and above

Exclusion Criteria

• Congenital diaphragmatic hernia
• Congenital heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volume-targeted ventilation	Ventilation delivered by SLE5000 ventilator	-
Pressure-limited ventilation	Ventilation delivered by SLE5000 ventilator	-

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.	Data will be collected from the intensive care observation chart to determine the time at which the infant was successfully taken off of mechanical ventilation, assessed up to 4 weeks.

Trial Locations

Locations (2)

Neonatal Intensive Care Unit; 🇬🇧 London, United Kingdom

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom