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

King's College London

Status: Completed

Conditions: Neonatal Respiratory Failure

Treatments: Device: Ventilation protocol delivered by the SLE5000 ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT01531010

07/H0808/147-2

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mechanically ventilated
• <34 weeks gestation
• Within first 24 hours of life

Exclusion criteria

• Congenital diaphragmatic hernia
• Congenital heart disease
• Oesophageal atresia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Pressure-limited ventilation

Active Comparator group

Treatment:

Device: Ventilation protocol delivered by the SLE5000 ventilator

Volume-targeted ventilation

Active Comparator group

Treatment:

Device: Ventilation protocol delivered by the SLE5000 ventilator