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Trial registered on ANZCTR


Registration number
ACTRN12610000166077
Ethics application status
Approved
Date submitted
15/02/2010
Date registered
19/02/2010
Date last updated
15/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
High-flow Nasal Cannulae as Post-extubation Respiratory Support in Premature Infants: A Continuus Positive Airway Pressure Equivalent? (The HIPERSPACE Trial)
Scientific title
The HIPERSPACE Trial: Comparing the failure rate of high-flow nasal cannulae (HFNC) versus nasal continuous positive airway pressure (CPAP) as post-extubation respiratory support in premature infants with gestational age less than 32 weeks.
Secondary ID [1] 1414 0
None
Universal Trial Number (UTN)
Trial acronym
HIPERSPACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress syndrome 256803 0
Condition category
Condition code
Respiratory 256954 256954 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High-flow nasal cannulae (HFNC): This intervention involves delivering flow rates of gas (air/oxygen) at a minimum of 2 litres per minute via smaller nasal cannulae than those used with nasal CPAP. Infants randomised to HFNC will remain on this intervention until failure criteria or cessation criteria are met, with changes to flow rate at the discretion of the treating medical team. Infants who 'fail' (based on non-subjective clinical criteria) will be changed to nasal CPAP or re-intubated.
Intervention code [1] 256009 0
Treatment: Other
Intervention code [2] 256035 0
Treatment: Devices
Comparator / control treatment
Nasal continuous positive airway pressure: This intervention is the standard treatment to be used as the comparator. Nasal CPAP involves the delivery via binasal prongs of a regulated pressure of gas (air/oxygen) to the infant. Infants randomised to nCPAP will remain on this therapy until failure or cessation criteria are met, based on non-subjective clinical criteria. Infants who 'fail' will be re-intubated.
Control group
Active

Outcomes
Primary outcome [1] 257827 0
Failure of assigned treatment within seven (7) days of extubation. Failure will be defined by non-subjective clinical criteria including: 1. respiratory acidosis with on blood gas measurement 2. increasing oxygen requirement based on peripheral transcutaneous oxygen saturation measurement 3. clinically observed worsening apnoea, or 4. any emergency deemed to require re-intubation by the treating medical team.
Timepoint [1] 257827 0
Seven (7) days after the time of extubation
Secondary outcome [1] 263248 0
Reviewing the bedside charts and patient medical record retrospectively for the number of recorded episodes and duration of mechanical ventilation via an endotracheal tube.
Timepoint [1] 263248 0
Within 7 days from the randomised extubation
Secondary outcome [2] 273164 0
Need for intubation and mechanical ventilation within the first 7 days from the randomised extubation. This will be recorded either prospective examination of the infant, or from the bedside charts or patient medical record retrospectively.
Timepoint [2] 273164 0
Within 7 days from randomised extubation
Secondary outcome [3] 273165 0
Bronchopulmonary dysplasia. This outcome is defined as the infant requiring respiratory support and/or supplemental oxygen at a corrected age of 36 weeks. This information will come from the patient's bedside charts or patient record.
Timepoint [3] 273165 0
Incidence recorded at 36 weeks corrected age
Secondary outcome [4] 273166 0
Pneumothoraces after trial entry. This will be noted prospectively by examining the infant, or from the patient's medical record.
Timepoint [4] 273166 0
Incidence continuously monitored until discharge from hospital
Secondary outcome [5] 273167 0
Nasal septum or skin trauma whilst receiving assigned treatment. A nasal trauma chart has been designed for the trial which will be completed on each nursing shift by the nurse caring for the infant. These charts will be collected and episodes of nasal trauma will be noted. Subsequent management of the nasal trauma will be noted from the patient's medical record.
Timepoint [5] 273167 0
Incidence continuously monitored until discharge from hospital

Eligibility
Key inclusion criteria
Mechanically ventilated infants with gestational age less than 32 weeks Being extubated to respiratory support Inborn or outborn Prospective consent obtained
Minimum age
0 Days
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known major respiratory or cardiac anomalies
Prospective consent not obtained

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2010
Actual
31/05/2010
Date of last participant enrolment
Anticipated
Actual
3/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256511 0
University
Name [1] 256511 0
University of Melbourne
Country [1] 256511 0
Australia
Funding source category [2] 256512 0
Hospital
Name [2] 256512 0
Murdoch Childrens Research Institute
Country [2] 256512 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Davis
Address
Department of Newborn Research
Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 255835 0
None
Name [1] 255835 0
Address [1] 255835 0
Country [1] 255835 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258574 0
Royal Women's Hospital Human Research and Ethics Committee
Ethics committee address [1] 258574 0
20 Flemington Road
Parkville
Victoria 3052
Ethics committee country [1] 258574 0
Australia
Date submitted for ethics approval [1] 258574 0
16/03/2010
Approval date [1] 258574 0
Ethics approval number [1] 258574 0

Summary
Brief summary
HIPERSPACE is a trial comparing the use of two types of breathing support for premature infants after they have been extubated (come off a mechanical breathing machine) in the Royal Women’s Hospital (RWH), Adelaide Women's and Children's Hospital (WCH) or Royal Brisbane and Women's Hospital (RBWH) neonatal intensive care units. Premature infants who are born less than 32 weeks of gestation, required support from a mechanical breathing machine, and are planned to be extubated to further breathing support are eligible for inclusion in the trial. The usual way post-extubation breathing support has been provided is by using large prongs in the babies’ nose which transmit a continuous, and regulated, pressure to the baby’s lungs to help them breathe more easily. This support, called nasal CPAP, is quite bulky and requires the infant to wear a tightly-fitted hat, and sometimes causes damage to the infants’ nose. A newer form of support being used around Australian and the world is called high-flow nasal cannulae (HFNC). This method uses smaller prongs in the infant’s nose and blows gas at 2-8 litres per minute into the infant’s airway. It is thought this flow also produces a pressure that helps to keep the lungs open, and has been considered to be more comfortable for the infants. However, despite widespread use, HFNC has not been well studied in premature infants. In the HIPERSPACE trial, premature infants who have been extubated will be randomly assigned to receive either nCPAP or HFNC. The main result we will be interested in from the trial will be which treatment the infants do better on. Infants in the HFNC group who are not coping can be offered nCPAP as ‘rescue’ treatment. Information will be collected about the infants until they are discharged from hospital, including the incidence of lung complications, the amount of different types of breathing support required, rates of complications from using the different types of prongs in the nose, and the comfort of the infant.
Trial website
HIPERSPACE is a trial comparing the use of two types of breathing support for premature infants after they have been extubated (come off a mechanical breathing machine) in the Royal Women’s Hospital (RWH) or Adelaide Women's and Children's Hospital (WCH) neonatal intensive care unit. Premature infants who are born less than 32 weeks of gestation, required support from a mechanical breathing machine, and are planned to be extubated to further breathing support are eligible for inclusion in the trial. The usual way post-extubation breathing support has been provided is by using large prongs in the babies’ nose which transmit a continuous, and regulated, pressure to the baby’s lungs to help them breathe more easily. This support, called nasal CPAP, is quite bulky and requires the infant to wear a tightly-fitted hat, and sometimes causes damage to the infants’ nose. A newer form of support being used around Australian and the world is called high-flow nasal cannulae (HFNC). This method uses smaller prongs in the infant’s nose and blows gas at 2-8 litres per minute into the infant’s airway. It is thought this flow also produces a pressure that helps to keep the lungs open, and has been considered to be more comfortable for the infants. However, despite widespread use, HFNC has not been well studied in premature infants. In the HIPERSPACE trial, premature infants who have been extubated will be randomly assigned to receive either nCPAP or HFNC. The main result we will be interested in from the trial will be which treatment the infants do better on. Infants in the HFNC group who are not coping can be offered nCPAP as ‘rescue’ treatment. Information will be collected about the infants until they are discharged from hospital, including the incidence of lung complications, the amount of different types of breathing support required, rates of complications from using the different types of prongs in the nose, and the comfort of the infant.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30832 0
Dr Brett Manley
Address 30832 0
Newborn Research Centre
The Royal Women's Hospital
Level 7, 20 Flemington Road
Parkville, VIC 3052
Australia
Country 30832 0
Australia
Phone 30832 0
+61383453766
Fax 30832 0
Email 30832 0
[email protected]
Contact person for public queries
Name 14079 0
Dr Brett Manley
Address 14079 0
Department of Newborn Research
Level 7, Royal Women's Hospital
20 Flemington Road
Parkville, Victoria, 3052
Country 14079 0
Australia
Phone 14079 0
+613 8345 3766
Fax 14079 0
Email 14079 0
[email protected]
Contact person for scientific queries
Name 5007 0
Dr Brett Manley
Address 5007 0
Department of Newborn Research
Level 7, Royal Women's Hospital
20 Flemington Road
Parkville, Victoria, 3052
Country 5007 0
Australia
Phone 5007 0
+613 8345 3766
Fax 5007 0
Email 5007 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
EmbaseExtubating extremely preterm infants: Predictors of success and outcomes following failure.2016https://dx.doi.org/10.1016/j.jpeds.2016.02.016
N.B. These documents automatically identified may not have been verified by the study sponsor.