NCT01376544

Brief Summary

During assist control ventilation and pressure support ventilation (PSV), the start of ventilator inflation is determined by the start of the infant's inspiratory effort. During PSV, termination of inflation is determined by the level of the infant's inspiratory flow. In a randomized trial, no significant differences were found between assist control and pressure support ventilation with regard to the duration of weaning, time to successful extubation, work of breathing, rate of asynchrony and level of respiratory muscle strength.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
Last Updated

June 20, 2011

Status Verified

June 1, 2011

Enrollment Period

2 years

First QC Date

May 26, 2011

Last Update Submit

June 17, 2011

Conditions

Neonatal Respiratory Failure

Keywords

NeonateWeaningAssist control ventilationPressure support ventilation

Outcome Measures

Primary Outcomes (1)

  • To determine which mode of ventilation was associated with a shorter duration of weaning.

    Up to 28 days after birth

Secondary Outcomes (1)

  • Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength

    Baseline, 24 hours and prior to extubation

Study Arms (2)

Assist control ventilation

ACTIVE COMPARATOR

Assist control ventilation

Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)

Pressure support ventilation

ACTIVE COMPARATOR
Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)

Interventions

Treatment protocol designed to evaluate (SLE 5000 ventilator)DEVICE

Assist control ventilation and pressure support ventilation

Also known as: SLE 5000 ventilator
Assist control ventilationPressure support ventilation

Eligibility Criteria

Age1 Day - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ventilated neonates less than 14 days of age

You may not qualify if:

  • Congenital heart disease, hypoxic ischaemic encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit

London, SE5 9RS, United Kingdom

Location

Study Officials

  • Anne Greenough, MD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 26, 2011

First Posted

June 20, 2011

Study Start

August 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

June 20, 2011

Record last verified: 2011-06

Locations

GB(1)