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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
  Purpose

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.


Condition Intervention
Neonatal Respiratory Failure
 Device: Ventilation protocol delivered by the SLE5000 ventilator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King's College London:

Primary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pressure-limited ventilation 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: Volume-targeted ventilation 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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital diaphragmatic hernia
  • Congenital heart disease
  • Oesophageal atresia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531010

Locations
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College London
  More Information

No publications provided

Responsible Party: Anne Greenough, Professor of Neonatology and Clinical Respiratory Physiology, King's College London
ClinicalTrials.gov Identifier: NCT01531010     History of Changes
Other Study ID Numbers: 07/H0808/147-2
Study First Received: February 8, 2012
Last Updated: February 8, 2012
Health Authority: United Kingdom: South East London Research Ethics Committee 3
United Kingdom: National Health Service

Keywords provided by King's College London:
Neonate
Premature
Pressure limited ventilation
Volume ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013