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Pilot trial of the "Slider" continuous positive airway pressure (CPAP) therapy prongs for use in neonates with respiratory distress syndrome

Pilot trial of the efficacy of "Slider" continuous positive airway pressure (CPAP) therapy prongs for use in neonates with respiratory distress syndrome

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000577718
Enrollment
30
Registered
2022-04-19
Start date
2024-06-03
Completion date
2026-05-31
Last updated
2024-04-01

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

Conditions

None listed

Brief summary

Comparison of the Slider prong Continuous positive airway pressure (CPAP) interface to the standard Fisher and Paykel CPAP interface in terms of effectiveness for the management of neonatal respiratory distress syndrome, incidence of nasal trauma and acceptability to nursing staff and parents of babies with respiratory distress syndrome in the Mercy Womens Neonatal intensive care unit.

Interventions

The device will deliver continuous positive pressure (CPAP) to neonates with respiratory distress syndrome in place of the standard Fisher and Paykel prongs/mask. It will be utilized within the Mercy Womens Neonatal ICU by medical and nursing staff in neonates deemed appropriate. The duration of CPAP will be for the duration of clinical signs of respiratory distress syndrome in the baby. The mode of delivery of CPAP is via the Drager ventilator. In terms of recruitment, we hope to recruit 30 neo

The device will deliver continuous positive pressure (CPAP) to neonates with respiratory distress syndrome in place of the standard Fisher and Paykel prongs/mask. It will be utilized within the Mercy Womens Neonatal ICU by medical and nursing staff in neonates deemed appropriate. The duration of CPAP will be for the duration of clinical signs of respiratory distress syndrome in the baby. The mode of delivery of CPAP is via the Drager ventilator. In terms of recruitment, we hope to recruit 30 neonates within 1 year. The allocation is non-randomized and the first 30 infants recruited will receive the intervention. The location is within the Neonatal intensive care unit at the Mercy Womens Hospital which is a level 6 neonatal intensive care unit. Neonatal observations will be assessed by the chief investigator to assure adherence to the study protocol and correct use of the device

Sponsors

Melissa Weber
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
24 Hours to 2 Months
Healthy volunteers
No

Inclusion criteria

Neonates who are greater than 28 weeks gestational age who have been stable on conventional CPAP for 24 hours previously but still have respiratory distress syndrome requiring CPAP treatment.

Exclusion criteria

Instability on CPAP requiring additional respiratory support or ventilation Anatomical abnormalities impacting airway structure ie Cleft palate or Pierre Robin

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026