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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
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?
Secondary ID [1] 253538 0
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? 3383 0
Condition category
Condition code
Reproductive Health and Childbirth 3580 3580 0 0
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] 3110 0
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] 4437 0
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] 4437 0
when ventilation is no longer required
Secondary outcome [1] 7486 0
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] 7486 0
when ventilation is no longer required
Secondary outcome [2] 7487 0
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] 7487 0
During the first 10 minutes of life
Secondary outcome [3] 7488 0
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] 7488 0
During the first 10 minutes of life
Secondary outcome [4] 7489 0
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] 7489 0
during resuscitation in the delivery room
Secondary outcome [5] 7490 0
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] 7490 0
when ventilation is no longer required.
Secondary outcome [6] 7491 0
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] 7491 0
when ventilation is no longer required
Secondary outcome [7] 7492 0
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] 7492 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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] 3566 0
Government body
Name [1] 3566 0
National Health and Medical Research Council Program Grant
Address [1] 3566 0
GPO Box 1421 Canberra ACT 2601
Country [1] 3566 0
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] 3207 0
None
Name [1] 3207 0
Address [1] 3207 0
Country [1] 3207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5608 0
Ethics committee address [1] 5608 0
Ethics committee country [1] 5608 0
Date submitted for ethics approval [1] 5608 0
02/07/2008
Approval date [1] 5608 0
05/11/2008
Ethics approval number [1] 5608 0

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 28734 0
Address 28734 0
Country 28734 0
Phone 28734 0
Fax 28734 0
Email 28734 0
Contact person for public queries
Name 11891 0
Dr. Georg Schmoelzer
Address 11891 0
Neonatal Services The Royal Women's Hospital, 20 Flemington Road, Parkville, 3052, Vic
Country 11891 0
Australia
Phone 11891 0
+61 3 8345 3775
Fax 11891 0
+61 3 8345 3761
Email 11891 0
georg.schmoelzer@thewomens.org.au
Contact person for scientific queries
Name 2819 0
Dr. Georg Schmoelzer
Address 2819 0
Neonatal Services The Royal Women's Hospital, 20 Flemington Road, Parkville, 3052, Vic
Country 2819 0
Australia
Phone 2819 0
+61 3 8345 3775
Fax 2819 0
+61 3 8345 3761
Email 2819 0
georg.schmoelzer@thewomens.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary