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

Study Overview
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Brief Summary
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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. 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.

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

Conditions
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Neonatal Respiratory Failure

Intervention / Treatment
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* Device: Ventilation protocol delivered by the SLE5000 ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanically ventilated <34 weeks gestation Within first 24 hours of life Exclusion Criteria: Congenital diaphragmatic hernia Congenital heart disease Oesophageal atresia

Ages Eligible for Study
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Maximum Age: 24 Hours

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 protocol delivered by the SLE5000 ventilator<br>* 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.<br>|
| Active Comparator: Volume-targeted ventilation<br> | Device: Ventilation protocol delivered by the SLE5000 ventilator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonate, Premature, Pressure limited ventilation, Volume ventilation