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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Greenough, King's College London
ClinicalTrials.gov Identifier:
NCT01531010
First received: February 8, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted

February 8, 2012
February 8, 2012
July 2010
February 2012   (final data collection date for primary outcome measure)
Time to achieve weaning criteria [ Designated as safety issue: No ]
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
Same as current
No Changes Posted
Not Provided
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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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neonatal Respiratory Failure
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.

  • Active Comparator: Pressure-limited ventilation
    Intervention: Device: Ventilation protocol delivered by the SLE5000 ventilator
  • Active Comparator: Volume-targeted ventilation
    Intervention: Device: Ventilation protocol delivered by the SLE5000 ventilator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital diaphragmatic hernia
  • Congenital heart disease
  • Oesophageal atresia
Both
up to 24 Hours
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01531010
07/H0808/147-2
No
Anne Greenough, King's College London
King's College London
Not Provided
Not Provided
King's College London
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP