Neonatal Care, Biomedical Engineering
Many babies receive PAP therapy as a mode of respiratory support. It is well-established and commonly used in Neonatal Intensive Care Units (NICUs) around the world, supported by high-quality evidence and clinical literature.
However, it is also recognised that the interfaces available for PAP can be difficult for clinicians to apply and manage and may also be uncomfortable for newborns. The term interface refers to prongs and masks that are applied to infants or neonates receiving PAP.
The purpose of this unblinded research is to develop a new PAP device with improved comfort, sizing, and ease of care to the benefit of both newborn babies and nursing staff. The device has been trialled on over 150 infants and neonates with no serious complications.
- Category
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Trial status
Active, not recruiting
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Trial phase
Medical Device Pilot StudyEarly stage studies seeking initial evidence of safety and efficacy in small numbers of participants.
Trial contact details
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Contact person
Mothers and Babies Research Team
What you need to know
Who can take part?
The demographic for this research is neonates and infants (up to 12 months of age) receiving PAP therapy as a mode of respiratory support, as prescribed by the medical team at the Mater Mothers’ Hospital NICU. In the context of inclusion:
- The infants and neonates must be spontaneously breathing.
- The Parent(s) or Guardian(s) must be at least 18 years of age and must be able to give written informed consent for the child.
What is involved for you?
After a discussion with the nursing staff and a consenting process, the baby is placed on the JetPlane PAP interface and accessories following consultation with medical staff. In particular:
- The nurse will assess for comfort, sizing and fit. If your baby expresses discomfort at any stage, they will be switched to a standard PAP interface.
- Your baby will continue to receive PAP therapy via the new interface until the medical team decides they are ready to be weaned off therapy, need to undergo other procedures that would require other modes of respiratory support, or if the withdrawal criteria is met.
- In order to assess the interface, the nursing staff may take photographs and/or videos of your baby in the product as these help with product design. The devices are expected to obscure your babies face, and there will be no identifying factors in the images (such as ID bands). Very basic information may also be taken, such as the babies age and weight.
The alternative to treatment is for the neonate or infant to use the standard PAP interface that is used in the NICU. You are welcome to withdraw from the study at any time.
Trial dates
This trial will be open for enrolment in February 2023.
