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Trial registered on ANZCTR


Registration number
ACTRN12612000392864
Ethics application status
Approved
Date submitted
4/04/2012
Date registered
5/04/2012
Date last updated
11/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oropharyngeal airway for prevention of airway obstruction during positive pressure ventilation in preterm infants < 34 weeks gestation during neonatal resuscitation - a randomised trial
Scientific title
For preterm infants born less than 34 weeks gestation requiring intermittent positive pressure ventilation in the delivery room, does the use of an oropharyngeal airway with a face mask reduce the prevalence of airway obstruction compared to using a face mask alone?
Secondary ID [1] 262560 0
nil
Universal Trial Number (UTN)
U1111-1129-7550
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Resuscitation 268220 0
Premature birth 286236 0
Condition category
Condition code
Reproductive Health and Childbirth 268348 268348 0 0
Complications of newborn
Respiratory 286442 286442 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of an oropharyngeal airway during manual face mask intermittent positive pressure ventilation of newly born infants < 34 weeks gestation
Intervention code [1] 266892 0
Treatment: Devices
Comparator / control treatment
Use of a face mask alone during manual intermittent positive pressure ventilation of newly born infants < 34 weeks gestation
Control group
Active

Outcomes
Primary outcome [1] 286889 0
The prevalence of moderate to severe airway obstruction during mask intermittent positive pressure ventilation (IPPV) of preterm infants in the delivery room (DR). This will be measured by a respiratory function monitor.
Timepoint [1] 286889 0
Duration of IPPV received by the infant in the DR
Secondary outcome [1] 296915 0
Changes in heart rate and pre-ductal oxygen saturations in the first 10 minutes of life measured by a pulse oximeter placed on the right wrist.
Timepoint [1] 296915 0
First 10 minutes from birth
Secondary outcome [2] 296916 0
Intubation in the DR
Timepoint [2] 296916 0
Duration of DR resuscitation
Secondary outcome [3] 296917 0
Duration of ventilatory support in hospital
Timepoint [3] 296917 0
Duration of hospital stay in level 3 neonatal intensive care unit

Eligibility
Key inclusion criteria
Infants less than 34 weeks gestation born in a tertiary level perinatal unit receiving IPPV in the DR with access to a respiratory function monitor.
Minimum age
0 Hours
Maximum age
0 Hours
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants born less than 34 weeks and not receiving active resuscitation. Infants with a known congenital anomaly. infants > 33 weeks gestation.

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)
Two strata will be created by gestational age (24 - 27 weeks and 28-33 weeks). The unique trial number will be block randomized and computer generated externally. For each strata, these will be sealed in sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unique trial number will be block randomized and computer generated externally. The size of the blocks will be determined by statisticians and not revealed to the study investigators and/or the treating physicians.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/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)
VIC
Recruitment hospital [1] 5429 0
The Royal Women's Hospital - Parkville
Recruitment outside Australia
Country [1] 7700 0
Canada
State/province [1] 7700 0
Alberta

Funding & Sponsors
Funding source category [1] 285041 0
Government body
Name [1] 285041 0
National Health Medical and Research Council
Address [1] 285041 0
GPO Box 1421
Canberra ACT 2601
Country [1] 285041 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital, Melbourne
Address
20 Flemington Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 283903 0
None
Name [1] 283903 0
Address [1] 283903 0
Country [1] 283903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287047 0
The Royal Women's Hospital Research and Human Research Ethics Committees
Ethics committee address [1] 287047 0
20 Flemington Road
Parkville
VIC 3052
Ethics committee country [1] 287047 0
Australia
Date submitted for ethics approval [1] 287047 0
17/08/2011
Approval date [1] 287047 0
11/10/2011
Ethics approval number [1] 287047 0
11/40

Summary
Brief summary
Approximately 5-10% of newly born infants receive assistance in the delivery room to establish regular breathing. Healthcare workers provide artificial ventilation using a manual ventilation device and a face mask to fit around the infant’s nose and mouth. Several factors can reduce the effectiveness of mask ventilation. These include poor face mask application resulting in leak or airway obstruction and spontaneous movements of the baby. Airway obstruction may be due to inadvertent manual compression of the soft tissues of the neck, tongue and thus the trachea, or hyperextension or flexion of the head. In addition, if the face mask is held on the face too tight, it may obstruct the mouth and nose. Using a simple device such as an oropharyngeal airway may reduce the prevalence of obstruction during mask ventilation and lead to more effective mask ventilation. This randomized trial is investigating whether for newly born infants requiring positive pressure ventilation in the delivery room, does the use of an oropharyngeal airway with a face mask reduce the degree of airway obstruction compared to using a face mask alone. Physiological recordings of the resuscitation will be made measuring delivered and expired tidal volumes, prevalence and degree of airway obstruction as well as oxygen saturations and heart rate. Data will also be collected and compared between the groups on common neonatal morbidities including duration of assisted ventilation in the nursery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32827 0
Dr Omar Kamlin
Address 32827 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Vic 3052
Country 32827 0
Australia
Phone 32827 0
+61383453769
Fax 32827 0
Email 32827 0
omar.kamlin@thewomens.org.au
Contact person for public queries
Name 16074 0
Dr Omar Kamlin
Address 16074 0
Department of Newborn Research
Royal Women's Hospital
20 Flemington Road
Parkville
VIC 3052
Country 16074 0
Australia
Phone 16074 0
+61383453763
Fax 16074 0
+61383453789
Email 16074 0
omar.kamlin@thewomens.org.au
Contact person for scientific queries
Name 7002 0
Dr Omar Kamlin
Address 7002 0
Department of Newborn Research
Royal Women's Hospital
20 Flemington Road
Parkville
VIC 3052
Country 7002 0
Australia
Phone 7002 0
+61383453763
Fax 7002 0
+61383453789
Email 7002 0
omar.kamlin@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