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

Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531010

Enrollment

Registered

2012-02-10

Start date

2010-07-31

Completion date

2012-02-29

Last updated

2012-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Respiratory Failure

Keywords

Neonate, Premature, Pressure limited ventilation, Volume ventilation

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.

Interventions

DEVICEVentilation protocol delivered by the SLE5000 ventilator

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Hours

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026