ANZCTR - Registration

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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

8/12/2024

Date data sharing statement initially provided

8/12/2024

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]

Nil

Universal Trial Number (UTN)

U1111-1152-5059

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neonatal resuscitation

Extremely preterm infants

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Public Health

Health service research

Respiratory

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]

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]

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]

At resuscitation

Primary outcome [2]

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]

At resuscitation

Primary outcome [3]

Need for endotracheal intubation, which will be evaluated from patient's medical records

Timepoint [3]

Endotracheal intubation in delivery suite

Secondary outcome [1]

Duration of mechanical ventilation, which will be assessed by reviewing the patient's medical records

Timepoint [1]

The secondary outcome will be assessed at discharge from the Neonatal Intensive Care Unit

Secondary outcome [2]

Duration of hospital stay

Timepoint [2]

Duration of hospital stay will be assessed at discharge from neonatal nursery and will be recorded from patient's medical records

Secondary outcome [3]

Chronic lung disease, which is defined as need for supplemental oxygen and/or respiratory support at 36 weeks corrected gestational age

Timepoint [3]

36 weeks corrected gestational age

Secondary outcome [4]

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]

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?

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

5/12/2024

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Neonatal Intensive Care Unit, Westmead Hospital

Address [1]

Westmead Hospital
Hawkesbury Road
Westmead NSW 2145

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Resource Ethics Committee

Ethics committee address [1]

Western Sydney Local Health District
Research Office, Room 1072, level 1, Education Block
Westmead Hospital
Westmead
NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/01/2014

Ethics approval number [1]

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

Dr Dharmesh Shah

Address

Neonatal Intensive Care Unit
Level 3, Westmead Hospital,
Cnr Darcy and Hawkesbury Road
Westmead, NSW 2145

Country

Australia

Phone

61 2 9845 7375

Fax

61 2 9845 7490

dharmesh.shah@health.nsw.gov.au

Contact person for public queries

Name

Dharmesh Shah

Address

Neonatal Intensive Care Unit
Level 3, Westmead Hospital,
Cnr Darcy and Hawkesbury Road
Westmead, NSW 2145

Country

Australia

Phone

61 2 9845 7375

Fax

dharmesh.shah@health.nsw.gov.au

Contact person for scientific queries

Name

Mark Tracy

Address

Neonatal Intensive Care Unit
Level 3, Westmead Hospital,
Cnr Darcy and Hawkesbury Road
Westmead, NSW 2145

Country

Australia

Phone

61 2 9845 7375

Fax

mark.tracy@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	One-person versus two-person mask ventilation in preterm infants at birth: a pilot randomised controlled trial.	2023	https://dx.doi.org/10.1136/bmjpo-2022-001768

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically