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Pilot study: Randomised controlled trial of interface use during stabilisation of preterm infants in the delivery room

Pilot study: Randomised controlled trial of interface use during stabilisation of preterm infants in the delivery room - MOUNTAIN trial (Mask Or Use of Nasal Tube As INterface)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32567
Enrollment
40
Registered
2009-04-17
Start date
2009-05-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

respiratory distress of the preterm infant at birth

Interventions

Resuscitation will be with the allocated device either the nasal tube or the mask. In both groups the Neopuff, a mechanical resuscitator with a T-piece, will be used. Other than allocation of the ty

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: preterm infants, gestational age range 25-29 weeks (more than 25 weeks and not more than 28 weeks and 6 days).

Exclusion criteria

Exclusion criteria: antenatal diagnosed congenital anomalies of the cardial or respiratory system or anomalies incompatible with survival.

Design outcomes

Primary

MeasureTime frame
The need for intubation in the first 24 hours after birth

Secondary

MeasureTime frame
Any complication caused by use of the interface, bronchopulmonary dysplasia at 36 weeks of gestation, incidence of air leak, incidence of IVH, mortality before discharge from hospital.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)