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High-flow Nasal Cannulae as Post-extubation Respiratory Support in Premature Infants: A Continuus Positive Airway Pressure Equivalent? (The HIPERSPACE Trial)

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000166077
Acronym
HIPERSPACE
Enrollment
300
Registered
2010-02-19
Start date
2010-05-31
Completion date
2012-07-03
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Professor Peter Davis
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
0 to 6 Months
Healthy volunteers
No

Inclusion criteria

Mechanically ventilated infants with gestational age less than 32 weeks Being extubated to respiratory support Inborn or outborn Prospective consent obtained

Exclusion criteria

Known major respiratory or cardiac anomalies Prospective consent not obtained

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026