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

Primary Purpose

Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ventilation delivered by 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 Respiratory Insufficiency focused on measuring neonatal, respiratory, mechanical ventilation

Eligibility Criteria

1 Minute - 4 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mechanically ventilated
  • Born at gestation 34 weeks and above

Exclusion Criteria:

  • Congenital diaphragmatic hernia
  • Congenital heart disease

Sites / Locations

  • King's College Hospital NHS Foundation Trust
  • Neonatal Intensive Care Unit

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

Duration of mechanical ventilation
Data will be collected from the intensive care observation chart to determine the time at which the infant was successfully taken off of mechanical ventilation, assessed up to 4 weeks.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2015
Last Updated
February 3, 2015
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT02358460
Brief Title
Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns
Official Title
Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.
Detailed Description
Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants. Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited 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 or peak pressures of more than 30 cm of water. 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
Respiratory Insufficiency
Keywords
neonatal, respiratory, mechanical 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 delivered by SLE5000 ventilator
Intervention Description
In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination. 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
Duration of mechanical ventilation
Description
Data will be collected from the intensive care observation chart to determine the time at which the infant was successfully taken off of mechanical ventilation, assessed up to 4 weeks.
Time Frame
For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mechanically ventilated Born at gestation 34 weeks and above Exclusion Criteria: Congenital diaphragmatic hernia Congenital heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Greenough, MD
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Neonatal Intensive Care Unit
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 Term Newborns

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