Neonatal Respiratory Failure Clinical Trial
Official title:
Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 24 Hours |
Eligibility |
Inclusion Criteria: - Mechanically ventilated - <34 weeks gestation - Within first 24 hours of life Exclusion Criteria: - Congenital diaphragmatic hernia - Congenital heart disease - Oesophageal atresia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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