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Trial registered on ANZCTR


Registration number
ACTRN12616000768493
Ethics application status
Approved
Date submitted
7/06/2016
Date registered
10/06/2016
Date last updated
14/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Provision of positive pressure ventilation to term and late-preterm infants: Does a novel suction device reduce face mask leak compared with a conventional mask?
Scientific title
Provision of positive pressure ventilation to term and late-preterm infants: Does a novel suction device reduce face mask leak compared with a conventional mask?
Secondary ID [1] 289344 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SEAL: Suction mask in early aeration of the infant lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathing support in the delivery room for term and nearterm infants 298970 0
Condition category
Condition code
Respiratory 299033 299033 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 299034 299034 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mask ventilation will be performed using the suction mask (60 mm). Either CPAP or intermittent positive pressure ventilation will be performed by a neonatal resident, fellow or consultant.

The suction mask called Resusi-sure (LSR Health care, NSW, Australia) uses suction to create a seal between the mask and the infant’s face. This mask has a vacuum chamber between the inner and the outer rim and has a side port to connect to standard tubing used by suction apparatus on the resuscitation trolley. The mask has Australian Therapeutic Goods Administration approval (June 2015). A negative pressure of -75 mmHg will be used to form a seal and used for the duration of mask use.

All other devices are set up as per standard hospital guideline for a resuscitation of a term baby. The initial setups are flow 10 l/min, Pip 30, Peep 5, no humidity, FiO2 0.21 and are escalated according to the physicians discretion and the infants response to rescucitation.
Intervention code [1] 294921 0
Treatment: Devices
Comparator / control treatment
Mask ventilation will be performed using the conventional mask (standard size mask for these infants is 65 mm), this is the current standard of care at the Royal Women’s Hospital. Either CPAP or intermittent positive pressure ventilation will be performed by a neonatal resident, fellow or consultant.

The conventional mask is a Laerdal Silicone mask (Laerdal, Stavanger, Norway, size 0/1) which the standard mask use in this hospital for nearterm and term infants.
Control group
Active

Outcomes
Primary outcome [1] 298498 0
Face mask leak

The sensor of a neonatal respiratory monitor (NewLifeBox Neo-RSD, Advanced Life Diagnostics UG, Weener, Germany) will be placed between the T-piece and the mask to measure inflating pressures and gas flow. Expiratory leak will be calculated from the volume of gas that does not return back through the flow sensor on expiration, expressed as a percentage of the inspired volume.
Leak (%) = (inspired tidal volume - expired tidal volume) x 100 / inspired tidal volume
Timepoint [1] 298498 0
Continous monitoring within first 10 min of life during positive pressure ventilation.
Secondary outcome [1] 324382 0
Expiratory tidal volumes (VTe)

The sensor of a neonatal respiratory monitor (NewLifeBox Neo-RSD, Advanced Life Diagnostics UG, Weener, Germany) will be placed between the T-piece and the mask to measure inflating pressures and gas flow. The flow sensor is able to detect volume.
Timepoint [1] 324382 0
Continous monitoring within first 10 min of life during positive pressure ventilation.
Secondary outcome [2] 324383 0
Positive inspiratory pressure (PIP)

The sensor of a neonatal respiratory monitor (NewLifeBox Neo-RSD, Advanced Life Diagnostics UG, Weener, Germany) will be placed between the T-piece and the mask to measure inflating pressures and gas flow. The flow sensor is able to detect PIP.
Timepoint [2] 324383 0
Continous monitoring within first 10 min of life during positive pressure ventilation.
Secondary outcome [3] 324384 0
Positive end-expiratory pressure (PEEP)

The sensor of a neonatal respiratory monitor (NewLifeBox Neo-RSD, Advanced Life Diagnostics UG, Weener, Germany) will be placed between the T-piece and the mask to measure inflating pressures and gas flow. The flow sensor is able to detect PEEP.
Timepoint [3] 324384 0
Continous monitoring within first 10 min of life during positive pressure ventilation.
Secondary outcome [4] 324385 0
Oxygen saturation (SpO2)

An oximetry sensor (LNOP Neo sensor; Masimo, Irvine, California, USA) will be placed around the infant’s right wrist and connected to the pulse oximeter (Radical7 V5; Masimo) to measure peripheral oxygen saturation (SpO2) and heart rate (HR). Continuous data will be recorded.
Timepoint [4] 324385 0
Continous monitoring within first 10 min of life during positive pressure ventilation.
Secondary outcome [5] 324386 0
Heart rate (HR)

Oximetry: An oximetry sensor (LNOP Neo sensor; Masimo, Irvine, California, USA) will be placed around the infant’s right wrist and connected to the pulse oximeter (Radical7 V5; Masimo) to measure peripheral oxygen saturation (SpO2) and heart rate (HR). Continuous data will be recorded.
Timepoint [5] 324386 0
Continous monitoring within first 10 min of life during positive pressure ventilation.
Secondary outcome [6] 324387 0
Inspired oxygen (FiO2)

Oxygen analyser: The concentration of inspired oxygen (FiO2) will be measured with a Teledyne oxygen analyser (Teledyne Analytical Instruments, California, USA). The analyser will be inserted into the inspiratory limb Neopuff circuit. Continuous data will be recorded.
Timepoint [6] 324387 0
Continous monitoring within first 10 min of life during positive pressure ventilation.
Secondary outcome [7] 324388 0
Duration of mask ventilation

The duration of mask ventilation is beeing assessed by the researcher who is present at birth as well as by a webcam which is integrated into the monitor using the respiratory fuction monitor.
Timepoint [7] 324388 0
Within first 10 min of life during positive pressure ventilation.
Secondary outcome [8] 324389 0
Endotracheal intubation in the delivery room

The researcher who is present at birth will document if the baby needed to be intubated in the delivery room. In addition a webcam which is integrated into the monitor using the respiratory fuction monitor will document this as well.
Timepoint [8] 324389 0
Within first 10 min of life during positive pressure ventilation.
Secondary outcome [9] 324390 0
Spontaneous breathing patterns

a. To identify and define spontaneous breathing patterns (expiratory hold, slow expiration, crying, grunting, unbraked expiration patterns) we will use criteria defined in our previous work on breathing patterns. The most accurate method to analyse these patterns are by viewing the flow and volume curves recorded with the respiratory monitor.

(NewLifeBox Neo-RSD, Advanced Life Diagnostics UG, Weener, Germany) will be placed between the T-piece and the mask to measure inflating pressures and gas flow.
Timepoint [9] 324390 0
Within first 10 min of life during positive pressure ventilation.
Secondary outcome [10] 324391 0
Number of attempts of repositioning of the mask

The researcher who is present at birth will document the number of attempts of repositioning the mask. In addition a webcam which is integrated into the monitor using the respiratory fuction monitor will document this as well.
Timepoint [10] 324391 0
Within first 10 min of life during positive pressure ventilation.
Secondary outcome [11] 324392 0
Trauma (skin, ocular - if any) according to a self-designed scoring system
Grade 0: no mark visible
Grade 1: red mark on an infant’s face that replicates the shape of the face mask
Grade 2: bruising
Grade 3: broken skin
Timepoint [11] 324392 0
Within first 10 min of life during positive pressure ventilation.
Secondary outcome [12] 324393 0
Ocular trauma: Any ocular trauma (bruising, broken skin, subconjunctival haemorrhage)? (YES/NO)
Timepoint [12] 324393 0
Within first 10 min of life during positive pressure ventilation.
Secondary outcome [13] 324394 0
Time for red mark (if any) to resolve

The researcher who is present at birth will document the time for the red mark to resolve. In addition a webcam which is integrated into the monitor using the respiratory fuction monitor will document this as well.
Timepoint [13] 324394 0
Until red mark resolution (hourly assessments if necessary).
Secondary outcome [14] 324396 0
Admission to the neonatal intensive care unit (YES/NO)

The researcher who is present at birth will document if the baby needed to be admitted to the NISC.
Timepoint [14] 324396 0
After birth until being discharged.
Secondary outcome [15] 324397 0
Pneumothoraces (needing treatment (YES/NO)
(either needle or intercostal catheter)

This outcome is assesssed by review of medical records.
Timepoint [15] 324397 0
After admission until hospital discharge
Secondary outcome [16] 324398 0
Intubation (YES/NO) /time of intubation in the NISC

This outcome is assesssed by review of medical records.
Timepoint [16] 324398 0
After admission until hospital discharge

Secondary outcome [17] 324399 0
Duration of mechanical ventilation.

This outcome is assesssed by review of medical records.
Timepoint [17] 324399 0
After admission until hospital discharge
Secondary outcome [18] 324400 0
Duration of non-invasive support (CPAP/HF)

This outcome is assesssed by review of medical records.
Timepoint [18] 324400 0
After admission until hospital discharge
Secondary outcome [19] 324401 0
Duration of additional oxygen requirement

This outcome is assesssed by review of medical records.
Timepoint [19] 324401 0
After admission until hospital discharge.
Secondary outcome [20] 324402 0
Surfactant administration (YES/NO)

This outcome is assesssed by review of medical records.
Timepoint [20] 324402 0
After admission until hospital discharge
Secondary outcome [21] 324403 0
Inotropes administered (YES/NO)

This outcome is assesssed by review of medical records.
Timepoint [21] 324403 0
After admission until hospital discharge
Secondary outcome [22] 324404 0
Death (YES/NO)
Timepoint [22] 324404 0
After admission until hospital discharge

Eligibility
Key inclusion criteria
term and late preterm appropriately grown infants with gestational age (GA) at birth greater than or equal to 34 weeks AND who require either CPAP (continuous positive airway pressure) or IPPV (intermittent positive pressure ventilation) in the delivery room/ operating theatre within the first 10 minutes after birth.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* congenital anomaly of the face, which may affect the ability of a mask to create a seal.
* inability of research team to attend
* not eligible for Medicare

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)
Allocation is 1:1. variable block randomisation will be used to ensure balance is achieved over the recruiting period. Sealed consecutively numbered opaque envelopes will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation is 1:1. variable block randomisation will be used to ensure balance is achieved over the recruiting period. There will be no stratification.
The sequence of randomisation will be generated by an independent statistician. Sealed consecutively numbered opaque envelopes will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
It is not possible to blind the operator to mask allocation. However, it possible to blind clinicians to the respiratory function measurements (leak and tidal volume). The monitor is designed so that researchers can black out the screen whilst continuing to collect data.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
We used human studies to inform the sample size calculation. There are several published studies including one RWH study published in 2010, that have reported the percentage face mask leak during resuscitation of preterm infants in the delivery room. Most recently Cheung et al. reported a mean of 30% (SD 17) which is comparable to earlier studies. To achieve a 50% reduction in leak and reduce the leak from 30% (using the conventional mask) to 15% (using the suction mask) we will need 44 infants (22 in each group) with 80% power and a two-tailed alpha error of 0.05.

We predict that approximately 1/3 of term infants who have their delivery expedited by an obstetric intervention will transition relatively smoothly and either require very few positive pressure inflations (< 5) or only continuous positive airway pressure (CPAP). Face mask leak is difficult to assess by conventional physiological measures during the application of CPAP alone and assessing superiority of one device over another with five or less inflations could be potentially inaccurate. These infants will be excluded from the analysis of the primary outcome leak but will be included in the analysis of the secondary outcomes, such as oxygen saturation (SpO2), inspired oxygen (FiO2), heart rate (HR), differences in the rates of intubation, number of attempts of repositioning of the mask, duration that mask is applied to the infant’s face, and documentation of any local trauma.
Since the sample size is based on the primary outcome of face mask leak, we are planning to recruit 44 infants who receive more than five inflations of intermittent positive pressure ventilation. We anticipate that we will randomise approximately 14 additional patients who will subsequently be excluded from the primary analysis because they received either CPAP alone, or less than five inflations.


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)
VIC
Recruitment hospital [1] 5877 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 13322 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 293725 0
Hospital
Name [1] 293725 0
The Royal Women's Hospital
Address [1] 293725 0
20 Flemington Road
Parkville VIC 3052
Country [1] 293725 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
20 Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 292557 0
None
Name [1] 292557 0
Address [1] 292557 0
Country [1] 292557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295156 0
Human Research Ethics Committee
Ethics committee address [1] 295156 0
Research & Ethics Secretariat
Arthur Hui
20 Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 295156 0
Australia
Date submitted for ethics approval [1] 295156 0
20/04/2016
Approval date [1] 295156 0
07/06/2016
Ethics approval number [1] 295156 0
Project 16/08-SEAL Trial

Summary
Brief summary
Around 3-6% of newborn infants require positive pressure ventilation (PPV) in the delivery room (DR). However, delivering effective mask ventilation can be challenging, because of large leak around the mask. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation. A new face mask called Resusi-sure (LSR Health care, NSW, Australia) uses suction to create a seal between the mask and the infant’s face.
Primary objective is to test (in a randomised trial) the hypothesis that there will be less leak during intermittent positive pressure ventilation of term and near term infants (newly born infants greater than or equal to 34 weeks) in the delivery room if performed with the suction mask compared with the conventional mask.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66326 0
Dr Laila Lorenz
Address 66326 0
Newborn Research Department
The Royal Women's Hospital
20 Flemington Road
Parkville Melbourne, 3052 VIC
Country 66326 0
Australia
Phone 66326 0
+61-477799274
Fax 66326 0
Email 66326 0
laila.lorenz@thewomens.org.au
Contact person for public queries
Name 66327 0
Dr Laila Lorenz
Address 66327 0
Newborn Research Department
The Royal Women's Hospital
20 Flemington Road
Parkville Melbourne, 3052 VIC
Country 66327 0
Australia
Phone 66327 0
+61-477799274
Fax 66327 0
Email 66327 0
laila.lorenz@thewomens.org.au
Contact person for scientific queries
Name 66328 0
Dr Laila Lorenz
Address 66328 0
Newborn Research Department
The Royal Women's Hospital
20 Flemington Road
Parkville Melbourne, 3052 VIC
Country 66328 0
Australia
Phone 66328 0
+61-477799274
Fax 66328 0
Email 66328 0
laila.lorenz@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