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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure-limited ventilation | Active Comparator |
| |
| Volume-targeted ventilation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital NHS Foundation Trust | London | London | SE5 9RS | United Kingdom |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| D000091642 | Urogenital Diseases |