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

Not Applicable

Completed

• Conditions: Neonatal Respiratory Failure
• Interventions: Device: Ventilation protocol delivered by the SLE5000 ventilator

• Registration Number: NCT01531010
• Lead Sponsor: King's College London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-08
• Last Update Submitted: 2012-02-08
• Study First Posted: 2012-02-10
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

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

Inclusion Criteria

• Mechanically ventilated
• <34 weeks gestation
• Within first 24 hours of life

Exclusion Criteria

• Congenital diaphragmatic hernia
• Congenital heart disease
• Oesophageal atresia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to achieve weaning criteria		Peak inspiratory pressure (PIP) of 16 cm of water or less AND fraction of inspired oxygen of 0.4 or less for at least 6 hours

Trial Locations

Locations (1)

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