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

Study Overview
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Brief Summary
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A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.

Detailed Description
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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.

Official Title
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Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: Ventilation delivered by SLE5000 ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanically ventilated Born at gestation 34 weeks and above Exclusion Criteria: Congenital diaphragmatic hernia Congenital heart disease

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pressure-limited ventilation<br> | Device: Ventilation delivered by SLE5000 ventilator<br>* In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination. 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.<br>|
| Active Comparator: Volume-targeted ventilation<br> | Device: Ventilation delivered by SLE5000 ventilator<br>* In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal, respiratory, mechanical ventilation