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Trial registered on ANZCTR
Registration number
ACTRN12607000186459
Ethics application status
Approved
Date submitted
4/10/2006
Date registered
30/03/2007
Date last updated
30/03/2007
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does the use of an introducer (stylet) improve the success rate at orotracheal intubation in newborn infants?
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Scientific title
Does the use of an introducer (stylet) improve the success rate at orotracheal intubation in newborn infants?
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Universal Trial Number (UTN)
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Trial acronym
STINT Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Orotracheal Intubation of Newborn Infants
1704
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Condition category
Condition code
Reproductive Health and Childbirth
1796
1796
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0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Newborn infants who require intubation and ventilation, from birth until time of discharge from the level 3 neonatal unit, as deemed necessary by the attending doctor will be randomised to intubation with (intervention group) an introducer (stylet). A single intubation attempt should usually take no longer than 60 seconds but multiple attempts are often reuired. For the purposes of this study only the first attempt will be randomised. The duration of ventilation will be determined by the doctor responsible for the infant and is not an outcome in this study.
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Intervention code [1]
1366
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Treatment: Devices
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Comparator / control treatment
Newborn infants who require intubation and ventilation, from birth until time of discharge from the level 3 neonatal unit, as deemed necessary by the attending doctor will be randomised to intubation without (control group) an introducer (stylet).
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome will be the success rate of intubation using the allocated method
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Assessment method [1]
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Timepoint [1]
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Immediately after the randomisation takes place and the intubation is attempted.
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Secondary outcome [1]
4336
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Duration of intubation attempt
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Assessment method [1]
4336
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Timepoint [1]
4336
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Secondary outcome [2]
4337
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Physiological instability during intubation attempt (oxygen saturation and heart rate)
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Assessment method [2]
4337
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Timepoint [2]
4337
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Secondary outcome [3]
4338
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Rates of complications associated with each method - airway trauma, incorrect (Endotracheal Tube) ETT placement or dislodgement.
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Assessment method [3]
4338
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Timepoint [3]
4338
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All complications will be recorded within 24 hours of intubation.
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Eligibility
Key inclusion criteria
All newborn infants requiring orotracheal intubation for ventilatory support from birth until discharge from the level 3 neonatal unit. This may include infants up to term gestation corrected (up to 16 weeks of postnatal life).
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Minimum age
Not stated
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Maximum age
16
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Excluded if infant's condition does not allow time for randomisation.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation). Stratified into 2 groups according to site of intubation.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/08/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
1949
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Hospital
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Name [1]
1949
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Royal Women's Hospital
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Address [1]
1949
0
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Country [1]
1949
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Australia
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Primary sponsor type
Hospital
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Name
Royal Women's Hospital, Carlton, Victoria
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
1761
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Country [1]
1761
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
3626
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Royal Women's Hospital
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Ethics committee address [1]
3626
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Ethics committee country [1]
3626
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Australia
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Date submitted for ethics approval [1]
3626
0
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Approval date [1]
3626
0
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Ethics approval number [1]
3626
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06/19
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Summary
Brief summary
Orotracheal intubation of newborn infants requiring respiratory support is difficult and often requires multiple attempts. Oral intubation may be performed using an endotracheal tube on its own or with an introducer (stylet) to help guide the insertion. We hypothesise that intubation is more frequently successful and performed quicker using an endotracheal tube with an introducer (stylet) than without and may be the preferred method of intubating newborn infants.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
27593
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Contact person for public queries
Name
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Liam O'Connell
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Address
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Royal Women's Hospital,
132 Grattan Street,
Carlton, VIC 3053
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Country
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Australia
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Phone
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03 9344 2000
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Fax
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03 9347 2731
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Email
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[email protected]
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Contact person for scientific queries
Name
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Liam O'Connell
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Address
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Royal Women's Hospital
132 Grattan Street
Carlton VIC 3053
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Country
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Australia
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Phone
1483
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03 9344 2000
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Fax
1483
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03 9347 2731
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Email
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[email protected]
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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
Embase
Orotracheal intubation in infants performed with a stylet versus without a stylet.
2017
https://dx.doi.org/10.1002/14651858.CD011791.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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