Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000062426
Ethics application status
Approved
Date submitted
8/01/2007
Date registered
19/01/2007
Date last updated
15/06/2021
Date data sharing statement initially provided
15/06/2021
Date results information initially provided
15/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
In extremely low birth weight (ELBW) infants who require positive pressure at birth does the Neopuff Infant Resuscitator compared with the Laerdal Infant Bag improve oxygen saturation measurements in the first ten minutes of life?
Scientific title
In extremely low birth weight (ELBW) infants who require positive pressure at birth does the Neopuff Infant Resuscitator compared with the Laerdal Infant Bag improve oxygen saturation measurements in the first ten minutes of life?
Universal Trial Number (UTN)
Trial acronym
The Resuscitation Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxygen saturation in the first ten minutes of life in infants born at less than 29 weeks gestation who require positive pressure ventilation 1555 0
Condition category
Condition code
Reproductive Health and Childbirth 1655 1655 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial of the Laerdal infant resuscitator (control) to provide positive pressure ventilation (in line with the Australian Resuscitation Council guidelines) during resuscitation of infants born at less than 29 weeks gestation. The duration of the trial is 18 months, we anticipate completing recruitment in August 2008.
Intervention code [1] 1536 0
Treatment: Devices
Comparator / control treatment
A randomised controlled trial of the Neopuff (comparator) to provide positive pressure ventilation (in line with the Australian Resuscitation Council guidelines) during resuscitation of infants born at less than 29 weeks gestation.
Control group
Active

Outcomes
Primary outcome [1] 2290 0
The difference in oxygenation saturation from the first measurement soon after birth until 10 minutes of age.
Timepoint [1] 2290 0
Measured soon after birth until 10 minutes of age
Secondary outcome [1] 3993 0
1. Time for heart rate to rise above 100 bpm
Timepoint [1] 3993 0
Measured soon after birth until 10 minutes of age.
Secondary outcome [2] 3994 0
2. Incidence of intubation and ventilation in the first 24 hours of life.
Timepoint [2] 3994 0
Measured at 24 hours of age.
Secondary outcome [3] 3995 0
3. Tidal volumes delivered during the first 10 minutes of life
Timepoint [3] 3995 0
Measured soon after birth until 10 minutes of age.
Secondary outcome [4] 3996 0
4. To determine whether the response to each device varies with:
a. gestational age
b. type of birth (vaginal or caesarean)
c. absence/presence of labour
d. antenatal steroids
Timepoint [4] 3996 0
Measured soon after birth until 10 minutes of age.

Eligibility
Key inclusion criteria
All infants born <29 weeks gestation in need of positive pressure ventilation, because of inadequate respiration and/or a heart rate of less than one hundred beats per minute (HR <100 bpm) will be eligible for resuscitation and therefore entry to this study.
Minimum age
0 Days
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants will be excluded from final analysis if they have a condition that might have an adverse effect on breathing or ventilation apart from prematurity or asphyxia.

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 containing the allocation will be opened by the senior doctor pjust before birth. Allocation will be stratified by gestational age (23-26 and 27-28 weeks)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated variable block size
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
14/02/2007
Date of last participant enrolment
Anticipated
Actual
13/02/2009
Date of last data collection
Anticipated
Actual
13/02/2009
Sample size
Target
76
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1801 0
Government body
Name [1] 1801 0
National Health and Medical Research Council Program Grant
Country [1] 1801 0
Australia
Primary sponsor type
Individual
Name
Professor Colin J Morley
Address
Neonatal Services
The Royal Women's Hospital
Cnr Grattan St and Flemington Road
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 1620 0
None
Name [1] 1620 0
Nil
Address [1] 1620 0
Country [1] 1620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3362 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 3362 0
The Royal Women's Hospital
Cnr Grattan St and Flemington Road
Parkville Victoria 3052
Ethics committee country [1] 3362 0
Australia
Date submitted for ethics approval [1] 3362 0
Approval date [1] 3362 0
27/10/2006
Ethics approval number [1] 3362 0
06/36

Summary
Brief summary
While positive end expiratory pressure (PEEP) is always used during intermittent positive pressure ventilation (IPPV), there are no current recommendations about the use of PEEP or continuous positive airway pressure (CPAP) during neonatal resusciation.

The Neopuff is a manual ventilation device which delivers PEEP or CPAP. The Laerdal bag is the commonest manual ventilation device in use worldwide and does not deliver PEEP.

Our hypothesis is that the delivery of PEEP or CPAP to very premature infants at birth may lead to a more rapid improvement in lung volume and therefore oxygenation.
Trial website
Trial related presentations / publications
Dawson JA , Schmölzer, G, Kamlin COF te Pas AB, Donath SM, O’Donnell CPF, Davis PG, Morley CJ. T-Piece versus self-inflating bag for ventilation of extremely preterm infants at birth, effect on oxygenation in the first five minutes: A randomised controlled trial Journal of Pediatrics 2011;158:912-8
Public notes

Contacts
Principal investigator
Name 27470 0
Address 27470 0
Country 27470 0
Phone 27470 0
Fax 27470 0
Email 27470 0
Contact person for public queries
Name 10725 0
Jennifer Dawson
Address 10725 0
The Royal Women's Hospital
Neonatal Services
Cnr Grattan St and Flemington Road
Parkville Victoria 3052
Country 10725 0
Australia
Phone 10725 0
+ 61 3 8354 3791
Fax 10725 0
+61 3 8345 3789
Email 10725 0
[email protected]
Contact person for scientific queries
Name 1653 0
Jennifer Dawson
Address 1653 0
Neonatal Services
Cnr Grattan St and Flemington Road
Parkville Victoria 3052
Country 1653 0
Australia
Phone 1653 0
+61 3 8345 3791
Fax 1653 0
+ 61 3 8345 3791
Email 1653 0
[email protected]

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
No additional documents have been identified.