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Does the use of an introducer (stylet) improve the success rate at orotracheal intubation in newborn infants?

Does the use of an introducer (stylet) improve the success rate at orotracheal intubation in newborn infants?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000186459
Acronym
STINT Study
Enrollment
300
Registered
2007-03-30
Start date
2006-08-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 l

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.

Sponsors

Royal Women's Hospital, Carlton, Victoria
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 16 Weeks
Healthy volunteers
No

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).

Exclusion criteria

Excluded if infant's condition does not allow time for randomisation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026