Skip to content

The MONT (Mask Or Nasal Tube) Trial: A randomised controlled trial of mask versus nasal tube for the stabilisation of preterm infants (born between 24 and 29 complete weeks gestation) in the delivery room.

A randomised controlled trial of mask versus nasal tube for the stabilisation of preterm infants (born between 24 and 29 complete weeks gestation) in the delivery room.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000230055
Acronym
MONT Trial
Enrollment
363
Registered
2010-03-19
Start date
2008-12-08
Completion date
2011-09-30
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

Most newly born extremely premature infants will receive help to establish breathing by the attending health professional. Face masks are standard but leak and this may lead to ineffective ventilation. Nasal tubes have been shown to improve chest wall movement in older infants and in more mature newly born infants was associated with less aggressive resuscitation. We hypothesize that nasal tubes may be gentler and hence better in stabilising the lungs of a newly born premature infant.

Interventions

Nasal tube to deliver continuous positive airway pressure (CPAP) and/or manual positive pressure inflations to newly born premature infants in the delivery room. The manual ventilating device is the Neopuff Infant Resuscitator used at standard hospital settings. Intervention is applied until patient has been stabilised and ready for transfer to the neonatal intensive care unit.

Sponsors

Royal Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
24 Weeks to 29 Weeks
Healthy volunteers
No

Inclusion criteria

Premature infants born between 24 and 29 weeks gestation at a participating hospital

Exclusion criteria

Infants with known congenital anomalies; infants receiving palliative care

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026