ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000357358

Ethics application status

Approved

Date submitted

9/07/2008

Date registered

25/07/2008

Date last updated

4/07/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

In extremely low birth weight (ELBW) infants who require positive pressure at birth does the use of a respiratory Function Monitor reduce face mask leak and improve the target tidal volume in the first ten minutes of life?

Scientific title

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Trial acronym

The Florian trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Does the use of a respiratory Function Monitor during positive pressure ventilation reduce face mask leak and improve the target tidal volume in the first ten minutes of life?

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A randomised controlled trial of a Respiratory Function Monitor during positive pressure ventilation during resuscitation of infants. A flowsensor will be placed between the mask and the Neopuff T-piece-device. This flowsensor measures the airflow and calculates the tidal volume. Each infant requiring positive pressure ventilation at birth will be recorded with the flowsensor in place, the duration of this recording will last during the initial stabilisation in the delivery room.
The duration of the trial is 12 months; we anticipate completing recruitment in October 2009.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Positive pressure ventilation (control) (in line with the Australian Resuscitation Council guidelines) during resuscitation of infants. Each infant requiring positive pressure ventilation at birth will be recorded with the flowsensor in place. In th ecomperator group the respiratory function monitor is masked, so that the operator can not see the display or hear any alarms of the repsiratory function monitor. The duration of this recording will last during the initial stabilisation in the delivery room.

Control group

Active

Outcomes

Primary outcome [1]

Reduction of Face mask leak during positive pressure ventilation
The leak is calculated in percentage of inspired tidal volume: leak in percentage= [(inspired tidal volume - expired tidal volume)/inspired tidal volume] * 100.
A t-test for statistical analysis will be performed

Timepoint [1]

when ventilation is no longer required

Secondary outcome [1]

Difference in the delivered tidal volumeThe inspired and the expired tidal volume is measured in both groups. A t-test for statistical analysis will be performed

Timepoint [1]

when ventilation is no longer required

Secondary outcome [2]

Changes in heart rate in the first ten minutes of life
A pulse oximeter will be used to record the heart rate during stabilisation. A Chi2 for statistical analysis will be performed

Timepoint [2]

During the first 10 minutes of life

Secondary outcome [3]

Changes in oxygen saturation in the first ten minutes of life
A pulse oximeter will be used to record the oxygen saturation during stabilisation. A Chi2 for statistical analysis will be performed.

Timepoint [3]

During the first 10 minutes of life

Secondary outcome [4]

Rate of intubation in the delivery room.
During stabilisation in the delivery room the rate of intubation in both groups will be measured. A Chi2 for statistical analysis will be performed

Timepoint [4]

during resuscitation in the delivery room

Secondary outcome [5]

Days of ventilation
The total days of ventilation support during hospital stay will be recorded for each individual baby and both groups will be compared, A Chi2 for statistical analysis will be performed

Timepoint [5]

when ventilation is no longer required.

Secondary outcome [6]

Days of respiratory support
The total days of respiratory (ventilation, CPAP, oxygen) support during hospital stay will be recorded for each individual baby and both groups will be compared, A Chi2 for statistical analysis will be performed

Timepoint [6]

when ventilation is no longer required

Secondary outcome [7]

Oxygen treatment at 36 weeks gestational age
If a baby still requires oxygen, CPAP of ventilation. A Chi2 for statistical analysis will be performed

Timepoint [7]

at corrected 36 weeks gestational age

Eligibility

Key inclusion criteria

Infants born in the Royal Women's Hospital who need positive pressure ventilation for resuscitation in the delivery room

Minimum age

0 Days

Maximum age

0 Days

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Infants will be excluded from final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: Congenital Diaphragmatic Hernia. Infants will also be excluded if their parents refuse to give consent to this study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sequentially numbered, sealed, opaque envelopes containing the allocation will be opened by the senior doctor just before birth.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomisation table from a statistic book

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

11/11/2008

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council Program Grant

Address [1]

GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Colin J Morley

Address

Neonatal Services The Royal Women's Hospital, 20 Flemington Road, Parkville, 3052, Vic

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

02/07/2008

Approval date [1]

05/11/2008

Ethics approval number [1]

Summary

Brief summary

A randomised controlled trial of a Respiratory Function Monitor during positive pressure ventilation (intervention) compared to positive pressure ventilation (control) (in line with the Australian Resuscitation Council guidelines) during resuscitation of infants. The duration of the trial is 12 months; we anticipate completing recruitment in October 2009.

Does the use of a respiratory Function Monitor during positive pressure ventilation reduce face mask leak and improve the target tidal volume in the first ten minutes of life?

During the stressful event of neonatal resuscitation neonatologists do not consider the tidal volume (VT) they deliver, or if there is a leak between the face and the mask.
We hypothesis that a respiratory function monitor will reduce the face mask leak and support the clinician to deliver the target tidal volume during positive pressure ventilation.
 

Ventilation using a face mask is the main technique used to support infants who breathe inadequately immediately after birth. However, a major problem is the often large and variable gas leak between the mask and face. Face mask leak occurs frequently, even for experienced operators and seriously affects the delivered tidal volume. The tidal volume changes as the leak changes, even though the same inflating pressure is used. In practice this means that for the same inflating pressure the tidal volume may be low, appropriate or excessive depending on the leak. 
Furthermore immediately after birth it is not possible to deliver an appropriate tidal volume using ventilation with a set pressure because the compliance of the lung varies from infant to infant and during the course of lung aeration. It is therefore necessary to measure and adjust the tidal volumes delivered during positive pressure ventilation in the minutes after birth, especially in very preterm infants.
We hypothesis that a respiratory function monitor will reduce the face mask leak and support the clinician to deliver the target tidal volume during positive pressure ventilation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Georg Schmoelzer

Address

Neonatal Services The Royal Women's Hospital, 20 Flemington Road, Parkville, 3052, Vic

Country

Australia

Phone

+61 3 8345 3775

Fax

+61 3 8345 3761

georg.schmoelzer@thewomens.org.au

Contact person for scientific queries

Name

Dr. Georg Schmoelzer

Address

Neonatal Services The Royal Women's Hospital, 20 Flemington Road, Parkville, 3052, Vic

Country

Australia

Phone

+61 3 8345 3775

Fax

+61 3 8345 3761

georg.schmoelzer@thewomens.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Expired CO2 Levels Indicate Degree of Lung Aeration at Birth	2013	https://doi.org/10.1371/journal.pone.0070895

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically