Pressure-limited Ventilation Versus Volume-targeted Ventilation in Preterm Newborns
NCT ID: NCT01531010
Last Updated: 2012-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2010-07-31
2012-02-29
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pressure-limited ventilation
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.
Volume-targeted ventilation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* \<34 weeks gestation
* Within first 24 hours of life
Exclusion Criteria
* Congenital heart disease
* Oesophageal atresia
24 Hours
ALL
No
Sponsors
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King's College London
OTHER
Responsible Party
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Anne Greenough
Professor of Neonatology and Clinical Respiratory Physiology
Locations
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King's College Hospital NHS Foundation Trust
London, London, United Kingdom
Countries
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Other Identifiers
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07/H0808/147-2
Identifier Type: -
Identifier Source: org_study_id
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