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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]

None

Universal Trial Number (UTN)

Trial acronym

HIPERSPACE

Linked study record

Health condition

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

Respiratory distress syndrome

Condition category

Condition code

Respiratory

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]

Treatment: Other

Intervention code [2]

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]

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]

Seven (7) days after the time of extubation

Secondary outcome [1]

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]

Within 7 days from the randomised extubation

Secondary outcome [2]

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]

Within 7 days from randomised extubation

Secondary outcome [3]

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]

Incidence recorded at 36 weeks corrected age

Secondary outcome [4]

Pneumothoraces after trial entry. This will be noted prospectively by examining the infant, or from the patient's medical record.

Timepoint [4]

Incidence continuously monitored until discharge from hospital

Secondary outcome [5]

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]

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?

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]

University

Name [1]

University of Melbourne

Address [1]

Royal Parade
Parkville,
Victoria, 3052

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Murdoch Childrens Research Institute

Address [2]

Royal Children's Hospital
Flemington Road
Parkville
Victoria 3052

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Women's Hospital Human Research and Ethics Committee

Ethics committee address [1]

20 Flemington Road
Parkville 
Victoria 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/03/2010

Approval date [1]

Ethics approval number [1]

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

Dr Brett Manley

Address

Newborn Research Centre
The Royal Women's Hospital
Level 7, 20 Flemington Road
Parkville, VIC 3052
Australia

Country

Australia

Phone

+61383453766

Fax

[email protected]

Contact person for public queries

Name

Dr Brett Manley

Address

Department of Newborn Research
Level 7, Royal Women's Hospital
20 Flemington Road
Parkville, Victoria, 3052

Country

Australia

Phone

+613 8345 3766

Fax

[email protected]

Contact person for scientific queries

Name

Dr Brett Manley

Address

Department of Newborn Research
Level 7, Royal Women's Hospital
20 Flemington Road
Parkville, Victoria, 3052

Country

Australia

Phone

+613 8345 3766

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Extubating extremely preterm infants: Predictors of success and outcomes following failure.	2016	https://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.

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Documents added manually

Documents added automatically