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

K

King's College London

Status

Completed

Conditions

Respiratory Insufficiency

Treatments

Device: Ventilation delivered by SLE5000 ventilator

Study type

Interventional

Funder types

Other

Identifiers

NCT02358460
07/H0808/147-3

Details and patient eligibility

About

A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.

Full description

Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants.

Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited 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 or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.

Enrollment

40 patients

Sex

All

Ages

1 minute to 4 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Mechanically ventilated
  • Born at gestation 34 weeks and above

Exclusion criteria

  • Congenital diaphragmatic hernia
  • Congenital heart disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Pressure-limited ventilation
Active Comparator group
Treatment:
Device: Ventilation delivered by SLE5000 ventilator
Volume-targeted ventilation
Active Comparator group
Treatment:
Device: Ventilation delivered by SLE5000 ventilator

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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