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

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.

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Key information

Conditions

Neonatal Respiratory Failure Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Congenital diaphragmatic hernia
Congenital heart disease
Oesophageal atresia

Treatment and study plan

Ventilation protocol delivered by the SLE5000 ventilator

Device

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Feb 10, 2012
Registry last updated: Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed