Pressure-limited Ventilation Versus Volume-targeted Ventilation in Preterm Newborns
Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 8, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedFebruary 10, 2012
February 1, 2012
1.6 years
February 8, 2012
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Pressure-limited ventilation
ACTIVE COMPARATORVolume-targeted ventilation
ACTIVE COMPARATORInterventions
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
You may qualify if:
- Mechanically ventilated
- \<34 weeks gestation
- Within first 24 hours of life
You may not qualify if:
- Congenital diaphragmatic hernia
- Congenital heart disease
- Oesophageal atresia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King's College Hospital NHS Foundation Trust
London, London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neonatology and Clinical Respiratory Physiology
Study Record Dates
First Submitted
February 8, 2012
First Posted
February 10, 2012
Study Start
July 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 10, 2012
Record last verified: 2012-02