Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neonatal Respiratory Failure
- Sponsor
- King's College London
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Time to achieve weaning criteria
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Anne Greenough
Professor of Neonatology and Clinical Respiratory Physiology
King's College London
Eligibility Criteria
Inclusion Criteria
- •Mechanically ventilated
- •\<34 weeks gestation
- •Within first 24 hours of life
Exclusion Criteria
- •Congenital diaphragmatic hernia
- •Congenital heart disease
- •Oesophageal atresia
Outcomes
Primary Outcomes
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