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

Primary Purpose

Neonatal Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ventilation protocol delivered by the SLE5000 ventilator
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Respiratory Failure focused on measuring Neonate, Premature, Pressure limited ventilation, Volume ventilation

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept 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

Sites / Locations

  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pressure-limited ventilation

Volume-targeted ventilation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 8, 2012
Last Updated
February 8, 2012
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT01531010
Brief Title
Pressure-limited Ventilation Versus Volume-targeted Ventilation in Preterm Newborns
Official Title
Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Failure
Keywords
Neonate, Premature, Pressure limited ventilation, Volume ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressure-limited ventilation
Arm Type
Active Comparator
Arm Title
Volume-targeted ventilation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Ventilation protocol delivered by the SLE5000 ventilator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to achieve weaning criteria
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mechanically ventilated <34 weeks gestation Within first 24 hours of life Exclusion Criteria: Congenital diaphragmatic hernia Congenital heart disease Oesophageal atresia
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

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

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