Infant Respiratory Interface and Accessories Evaluation Study

Launched by FISHER AND PAYKEL HEALTHCARE · Jan 31, 2023

Keywords

ClinConnect Summary

The Infant Respiratory Interface and Accessories Evaluation Study is a clinical trial aimed at testing a new device and its accessories designed to help newborns and infants who have trouble breathing, specifically those with a condition called Respiratory Distress Syndrome. The goal is to see how well this non-invasive therapy works in providing support to these young patients without needing to use more invasive methods.

To participate in the study, infants who are breathing on their own but need some extra help with their breathing may be eligible. Parents or guardians must be at least 18 years old and able to provide written consent to join the trial. However, families should know that infants with certain skull or airway problems, or those who do not need breathing support, will not be included. Participants can expect to provide feedback on the usability of the device and its accessories during the trial, which is not currently recruiting participants yet. This study could help improve breathing support for newborns in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Spontaneously breathing infants who require non-invasive respiratory support
• • Parent(s)/guardian(s) at least 18 years of age
• Exclusion Criteria:
• • Parent(s)/guardian(s) unable to give written informed consent
• • Neonate or infant not requiring non-invasive support
• • Suspected or confirmed abnormalities or trauma to the skull or airway