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Pressure Support Ventilation (PSV) or Synchronised Intermittent Mandatory Ventilation (SIMV) for weaning preterm infants on mechanical ventilation

Pressure Support Ventilation (PSV) or Synchronised Intermittent Mandatory Ventilation (SIMV) for weaning preterm infants on mechanical ventilation: a multi-centre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74272142
Enrollment
110
Registered
2011-03-08
Start date
2011-01-26
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Respiratory distress syndrome in preterm babies Respiratory Respiratory distress syndrome

Interventions

The intervention arm would receive pressure supported mechanical breaths for all the spontaneous breaths generated by the infant and the control arm would receive SIMV mode of respiratory support as i

Sponsors

North Tees and Hartlepool NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preterm infants with RDS, stratified into three groups (23+0 to 25+6, 26+0 to 28+6 and 29+0 to 31+6 weeks) based on their gestation at birth would be enrolled if they are needing mechanical ventilation through an endotracheal tube for at least 6 hours 2. Signed parental consent is obtained before randomisation

Exclusion criteria

Exclusion criteria: 1. Severe congenital malformation 2. Neuromuscular disorder demonstrated clinically with decreased muscular tone 3. Upper airway anomaly 4. Infants transferred from other unit who have met the study entry criteria on admission to the neonatal unit

Design outcomes

Primary

MeasureTime frame
The primary endpoint is duration of weaning on mechanical ventilation - defined as time from commencing weaning in the assigned mode of respiratory support to the time when the infant is ready for extuabtion demonstrated by passing the MVT

Secondary

MeasureTime frame
1. Total duration of mechanical support through the endotracheal (ET) tube 2. Total duration of respiratory support including non invasive respiratory support 3. Discharge on home oxygen 4. Complications of prematurity

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026