Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000245695
Ethics application status
Approved
Date submitted
21/02/2014
Date registered
7/03/2014
Date last updated
19/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on delivery suite mask ventilation in extremely preterm infants
Scientific title
A pilot study comparing the respiratory function parameters of 1-person and 2-person mask technique in delivery suite for extremely preterm infants on reducing mask leak
Secondary ID [1] 283967 0
Nil
Universal Trial Number (UTN)
U1111-1152-5059
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal resuscitation 290995 0
Extremely preterm infants 290996 0
Condition category
Condition code
Reproductive Health and Childbirth 291340 291340 0 0
Complications of newborn
Public Health 291602 291602 0 0
Health service research
Respiratory 291644 291644 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In 1-person method (which is the current standard technique) the resuscitator holds the mask in place with one hand and uses the other hand to provide positive pressure ventilation. In the 2-person method, one person holds the mask in place and the other person provides the positive pressure ventilation. Positive Pressure Ventilation(PPV) will be supplied if needed clinically as per International Liaison Commission on Resuscitation (ILCOR) guidelines using either a t-piece resuscitator (Neopuff (TM), Fisher & Paykel Healthcare, Auckland New Zealand) with starting settings of FiO2 30% Pressures of 25 cm H2O for peak inflation pressure and 5 cm H2O for positive end expiratory pressure. Self-inflating bag (Laerdal Medical, New York, USA) is also used routinely, as an alternative. Current routine care for premature infants born < 30wks gestation at Westmead includes the use of an intensive care newborn transport system that includes a neonatal ventilator, respiratory mechanics monitor and tissue saturation monitoring. A respiratory function monitor (Respironics NM3, Philips Healthcare, Best, The Netherlands) will be used in line with the mask to measure respiratory function parameters. This includes a sensitive end tidal CO2 monitor needed for clinical certainty for Endo Tracheal Tube (ETT) placement. A NIRS (Near Infra-Red Spectroscopy, Nonin Medical, Plymouth, Minnesota, USA) probe will be placed over the head to measure cerebral blood flow.
Intervention code [1] 288653 0
Treatment: Other
Comparator / control treatment
The control group will include infants randomized to the 1 person mask technique
Control group
Active

Outcomes
Primary outcome [1] 291331 0
Mask leak : Percentage mask leak is defined as (tidal volume inspired - tidal volume expired) / Tidal volume inspired x 100. This would be calculated by the NM3 respiratory function monitor.
Timepoint [1] 291331 0
At resuscitation
Primary outcome [2] 291332 0
Airways obstruction : Airways obstruction will be defined as a 75% reduction in expired tidal volume compared to the baseline of 10 inflations prior the obstructed inflation. This would be demonstrated on the NM3 respiratory funciton monitor.
Timepoint [2] 291332 0
At resuscitation
Primary outcome [3] 291333 0
Need for endotracheal intubation, which will be evaluated from patient's medical records
Timepoint [3] 291333 0
Endotracheal intubation in delivery suite
Secondary outcome [1] 306535 0
Duration of mechanical ventilation, which will be assessed by reviewing the patient's medical records
Timepoint [1] 306535 0
The secondary outcome will be assessed at discharge from the Neonatal Intensive Care Unit
Secondary outcome [2] 306536 0
Duration of hospital stay
Timepoint [2] 306536 0
Duration of hospital stay will be assessed at discharge from neonatal nursery and will be recorded from patient's medical records
Secondary outcome [3] 306537 0
Chronic lung disease, which is defined as need for supplemental oxygen and/or respiratory support at 36 weeks corrected gestational age
Timepoint [3] 306537 0
36 weeks corrected gestational age
Secondary outcome [4] 306538 0
Intraventricular hemorrhage, will be defined according to the papile classification (Grade I to grade IV) assessed routinely within 7 days and at 6 weeks of age
Timepoint [4] 306538 0
6 weeks of life

Eligibility
Key inclusion criteria
Preterm infants at <30 weeks gestation requiring respiratory support in delivery suite
Minimum age
0 Hours
Maximum age
0 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lethal congenital anomalies
Upper airway anomalies
Unavailability of the research team

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)
Computer generated randomization, concealed in an opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, stratified allocation (gestational age 23 to 26.6 weeks and 27 weeks to 29.6 weeks)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis will include for continuous outcome data, ANOVA for repeated measures where data is normally distributed and Generalized Estimating Equations (GEE) for data that fails normality significantly and cannot be rendered normal by transformation. Dichotomous outcome data will be examined with logistic regression.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/03/2014
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1996 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 7719 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 288791 0
Hospital
Name [1] 288791 0
Neonatal Intensive Care Unit, Westmead Hospital
Country [1] 288791 0
Australia
Primary sponsor type
Hospital
Name
Neonatal Intensive Care Unit, Westmead Hospital
Address
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 287309 0
None
Name [1] 287309 0
Address [1] 287309 0
Country [1] 287309 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290462 0
Human Resource Ethics Committee
Ethics committee address [1] 290462 0
Western Sydney Local Health District
Research Office, Room 1072, level 1, Education Block
Westmead Hospital
Westmead
NSW 2145
Ethics committee country [1] 290462 0
Australia
Date submitted for ethics approval [1] 290462 0
Approval date [1] 290462 0
16/01/2014
Ethics approval number [1] 290462 0
HREC2013/10/4.3(3831) AU RED HREC/13/WMEAD/329

Summary
Brief summary
Neonatal mask ventilation (artificial breathing) is a technique that requires mastering, and previous simulation
studies on manikin model suggest that mask leak is very common and significant in magnitude. Also airways
obstruction occurs frequently when a resuscitator tries to minimise leak. A few studies in extremely preterm infants
have suggested airways obstruction is common immediately after birth in infants requiring positive pressure ventilation. Studies in manikin models have described a simple 2-person
four hand technique of mask ventilation that halves mask leak. Current UK neonatal guidelines (2010)suggest to consider using 2-person airway control on the basis of manikin studies. We propose to compare the current 1 person mask technique (Australian Resuscitation Council guideline, 2010) to 2 person mask technique. There are no studies available to inform which method is better.
Aims : To measure respiratory function (lung function) parameters (mask leak, tidal volume, minute ventilation, end
tidal CO2), and cerebral blood flow while using 1-person vs 2-person mask technique in delivery suite for extremely
preterm infants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45754 0
Dr Dharmesh Shah
Address 45754 0
Neonatal Intensive Care Unit
Level 3, Westmead Hospital,
Cnr Darcy and Hawkesbury Road
Westmead, NSW 2145
Country 45754 0
Australia
Phone 45754 0
61 2 9845 7375
Fax 45754 0
61 2 9845 7490
Email 45754 0
[email protected]
Contact person for public queries
Name 45755 0
Dr Dharmesh Shah
Address 45755 0
Neonatal Intensive Care Unit
Level 3, Westmead Hospital,
Cnr Darcy and Hawkesbury Road
Westmead, NSW 2145
Country 45755 0
Australia
Phone 45755 0
61 2 9845 7375
Fax 45755 0
Email 45755 0
[email protected]
Contact person for scientific queries
Name 45756 0
A/Prof Mark Tracy
Address 45756 0
Neonatal Intensive Care Unit
Level 3, Westmead Hospital,
Cnr Darcy and Hawkesbury Road
Westmead, NSW 2145
Country 45756 0
Australia
Phone 45756 0
61 2 9845 7375
Fax 45756 0
Email 45756 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
EmbaseOne-person versus two-person mask ventilation in preterm infants at birth: a pilot randomised controlled trial.2023https://dx.doi.org/10.1136/bmjpo-2022-001768
N.B. These documents automatically identified may not have been verified by the study sponsor.