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

Neonatal Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531010
• Other study ID #: 07/H0808/147-2
• Status: Completed
• Phase: N/A
• First received: February 8, 2012
• Last updated: February 8, 2012
• Start date: July 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: South East London Research Ethics Committee 3United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

Inclusion Criteria:

• Mechanically ventilated

• <34 weeks gestation

• Within first 24 hours of life

Exclusion Criteria:

• Congenital diaphragmatic hernia

• Congenital heart disease

• Oesophageal atresia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Ventilation 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.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No