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Trial registered on ANZCTR


Registration number
ACTRN12610000230055
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
19/03/2010
Date last updated
9/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 1515 0
None
Universal Trial Number (UTN)
Trial acronym
MONT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neonatal resuscitation 4310 0
neonatal respiratory distress syndrome 4311 0
bronchopulmonary dysplasia 4312 0
Condition category
Condition code
Reproductive Health and Childbirth 257140 257140 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 4040 0
Treatment: Other
Comparator / control treatment
Face mask 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.
Control group
Active

Outcomes
Primary outcome [1] 5423 0
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.
Timepoint [1] 5423 0
First 24 hours after birth.
Secondary outcome [1] 9115 0
Rates of bronchopulmonary dysplasia defined as a need for either supplemental oxygen or positive pressure ventilation or both at 36 weeks corrected gestational age.
Timepoint [1] 9115 0
36 weeks corrected gestational age
Secondary outcome [2] 9116 0
Oxygen saturation (SpO2) and heart rate during stabilisation in the delivery room as measured using pulse oximetry.
Timepoint [2] 9116 0
First 10 minutes following birth
Secondary outcome [3] 9117 0
mortality
Timepoint [3] 9117 0
prior to hospital discharge
Secondary outcome [4] 9118 0
Serious intraventricular haemorrhage (grade 3 or greater) as diagnosed by ultrasonography
Timepoint [4] 9118 0
during hospital admission

Eligibility
Key inclusion criteria
Premature infants born between 24 and 29 weeks gestation at a participating hospital
Minimum age
24 Weeks
Maximum age
29 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with known congenital anomalies; infants receiving palliative care

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered sealed opaque envelopes will be opened prior to the birth of an extremely preterm infant (24 to 29 weeks gestation inclusively). Infants will be allocated one of two interfaces; either the face mask or nasal tube to be used with the Neopuff Infant Resuscitator to stabilise the infant in the delivery room
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be stratified by gestational age (24-25 weeks) and (26-29 weeks) and sequence generated by variable block size. The randomised sequence will be generated using statistical software by an independent statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
8/12/2008
Date of last participant enrolment
Anticipated
Actual
30/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
648
Accrual to date
Final
363
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5413 0
The Royal Women's Hospital - Parkville
Recruitment outside Australia
Country [1] 1566 0
Netherlands
State/province [1] 1566 0
Leiden

Funding & Sponsors
Funding source category [1] 4487 0
Government body
Name [1] 4487 0
National Health and Medical Research Council (NHMRC) Program Grant No 384100
Country [1] 4487 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
20 Flemington Road
Parkville
Vic 3052
Country
Australia
Secondary sponsor category [1] 4051 0
Government body
Name [1] 4051 0
NHMRC
Address [1] 4051 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 4051 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6548 0
Royal Women's Hospital Research And Human Research Ethics Committees
Ethics committee address [1] 6548 0
20 Flemington Road
Parkville
Victoria
3052
Ethics committee country [1] 6548 0
Australia
Date submitted for ethics approval [1] 6548 0
Approval date [1] 6548 0
07/04/2009
Ethics approval number [1] 6548 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29273 0
Dr Omar kamlin
Address 29273 0
Newborn Services
Royal Women's Hospital
20 flemington Road
Parkville VIC 3052
Country 29273 0
Australia
Phone 29273 0
+61393453769
Fax 29273 0
Email 29273 0
[email protected]
Contact person for public queries
Name 12520 0
Omar Kamlin
Address 12520 0
Newborn Services and Neonatal Research
7th floor
Royal Women's Hospital
20 Flemington Road
Parkville
Victoria
3052
Country 12520 0
Australia
Phone 12520 0
+61 3 8345 3769
Fax 12520 0
+61 3 8345 3789
Email 12520 0
[email protected]
Contact person for scientific queries
Name 3448 0
Omar Kamlin
Address 3448 0
Newborn Services and Neonatal Research
7th floor
Royal Women's Hospital
20 Flemington Road
Parkville
Victoria
3052
Country 3448 0
Australia
Phone 3448 0
+61 3 8345 3769
Fax 3448 0
+61 3 8345 3789
Email 3448 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
EmbaseMask versus nasal tube for stabilization of preterm infants at birth: Respiratory function measurements.2015https://dx.doi.org/10.1016/j.jpeds.2015.04.003
N.B. These documents automatically identified may not have been verified by the study sponsor.