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.
Not Applicable
Completed
- Conditions
- neonatal resuscitationneonatal respiratory distress syndromebronchopulmonary dysplasiaReproductive Health and Childbirth - Childbirth and postnatal care
- Registration Number
- ACTRN12610000230055
- Lead Sponsor
- Royal Women's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 648
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The need for endotracheal intubation in the first 24 hours after birth. Specific criteria have been established for the delivery room (need for cardiac massage, apnoea after 60 seconds of positive pressure ventilation, poor respiratory effort and heart rate <120bpm). After 10 minutes of age/once in the nursery any evidence of poor oxygenation [judged by CPAP pressure of 8cmH20 and 40% oxygen but peripheral oxygen saturations or SpO2 < 85%]), the infant can be intubated.[First 24 hours after birth.]
- Secondary Outcome Measures
Name Time Method Rates of bronchopulmonary dysplasia defined as a need for either supplemental oxygen or positive pressure ventilation or both at 36 weeks corrected gestational age.[36 weeks corrected gestational age];Oxygen saturation (SpO2) and heart rate during stabilisation in the delivery room as measured using pulse oximetry.[First 10 minutes following birth];mortality[prior to hospital discharge];Serious intraventricular haemorrhage (grade 3 or greater) as diagnosed by ultrasonography[during hospital admission]