Trial Review

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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?
Scientific title
Does the use of an introducer (stylet) improve the success rate at orotracheal intubation in newborn infants?
Universal Trial Number (UTN)
Trial acronym
STINT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orotracheal Intubation of Newborn Infants 1704 0
Condition category
Condition code
Reproductive Health and Childbirth 1796 1796 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1366 0
Treatment: Devices
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).
Control group
Active

Outcomes
Primary outcome [1] 2517 0
The primary outcome will be the success rate of intubation using the allocated method
Timepoint [1] 2517 0
Immediately after the randomisation takes place and the intubation is attempted.
Secondary outcome [1] 4336 0
Duration of intubation attempt
Timepoint [1] 4336 0
Secondary outcome [2] 4337 0
Physiological instability during intubation attempt (oxygen saturation and heart rate)
Timepoint [2] 4337 0
Secondary outcome [3] 4338 0
Rates of complications associated with each method - airway trauma, incorrect (Endotracheal Tube) ETT placement or dislodgement.
Timepoint [3] 4338 0
All complications will be recorded within 24 hours of intubation.

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).
Minimum age
Not stated
Maximum age
16 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded if infant's condition does not allow time for randomisation.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1949 0
Hospital
Name [1] 1949 0
Royal Women's Hospital
Country [1] 1949 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital, Carlton, Victoria
Address
Country
Australia
Secondary sponsor category [1] 1761 0
None
Name [1] 1761 0
None
Address [1] 1761 0
Country [1] 1761 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3626 0
Royal Women's Hospital
Ethics committee address [1] 3626 0
Ethics committee country [1] 3626 0
Australia
Date submitted for ethics approval [1] 3626 0
Approval date [1] 3626 0
Ethics approval number [1] 3626 0
06/19

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27593 0
Address 27593 0
Country 27593 0
Phone 27593 0
Fax 27593 0
Email 27593 0
Contact person for public queries
Name 10555 0
Liam O'Connell
Address 10555 0
Royal Women's Hospital,
132 Grattan Street,
Carlton, VIC 3053
Country 10555 0
Australia
Phone 10555 0
03 9344 2000
Fax 10555 0
03 9347 2731
Email 10555 0
[email protected]
Contact person for scientific queries
Name 1483 0
Liam O'Connell
Address 1483 0
Royal Women's Hospital
132 Grattan Street
Carlton VIC 3053
Country 1483 0
Australia
Phone 1483 0
03 9344 2000
Fax 1483 0
03 9347 2731
Email 1483 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseOrotracheal intubation in infants performed with a stylet versus without a stylet.2017https://dx.doi.org/10.1002/14651858.CD011791.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.