NCT02358460

Brief Summary

A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
Last Updated

February 9, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

January 13, 2015

Last Update Submit

February 3, 2015

Conditions

Respiratory Insufficiency

Keywords

neonatalrespiratorymechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (2)

Pressure-limited ventilation

ACTIVE COMPARATOR
Device: Ventilation delivered by SLE5000 ventilator

Volume-targeted ventilation

ACTIVE COMPARATOR
Device: Ventilation delivered by SLE5000 ventilator

Interventions

Ventilation delivered by SLE5000 ventilatorDEVICE

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.

Pressure-limited ventilationVolume-targeted ventilation

Eligibility Criteria

Age1 Minute - 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Mechanically ventilated
  • Born at gestation 34 weeks and above

You may not qualify if:

  • Congenital diaphragmatic hernia
  • Congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King's College Hospital NHS Foundation Trust

London, London, SE5 9RS, United Kingdom

Location

Neonatal Intensive Care Unit

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Anne Greenough, MD

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 9, 2015

Study Start

May 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 9, 2015

Record last verified: 2015-02

Locations

GB(2)