Airway Flow of RAM Cannula With BCPAP in Infants

Launched by KAROLINSKA INSTITUTET · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a device called the RAM Cannula, which is used to help newborn babies with breathing difficulties, specifically those receiving CPAP (Continuous Positive Airway Pressure) treatment. The researchers want to understand how well the RAM Cannula works compared to other breathing support systems, especially since it has not been extensively tested before. They will measure how air flows through the device and if babies can breathe out properly while using it. This study is important because it could provide new insights into whether the RAM Cannula is as effective as other methods that have been used for many years.

To participate in this trial, babies need to be admitted to the Phu San Hanoi Hospital Neonatology Unit and be stable while receiving bubble CPAP support with the RAM interface. They should be quiet and breathing on their own without major breathing issues. The study will involve a short data collection that takes about five minutes, during which the baby's breathing support will only be briefly interrupted. Throughout the process, the baby's vital signs will be closely monitored to ensure their safety. This research aims to gather valuable information that may help improve breathing support for newborns in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Admitted to Phu San Hanoi Hospital Neonatology Unit
• • Support with bubble CPAP and RAM interface
• • Quiet and stable spontaneous breathing
• • Investigation team available
• Exclusion Criteria:
• • Problems with routine CPAP care
• • Major congenital malformation
• • Known syndrome or neuromuscular disease
• • Circulatory instability with inotropes
• • Oxygen need \>50% or CPAP \>10 cm H2O
• • Surfactant given the last 6 hours or expected to be needed the next 6 hours
• • Expected to need NIPPV or intubation within 6 hours
• • Recently extubated (\<24 h)
• • Recent large surgical procedure (\<5 days)
• • Nasal wound or irritation that hurts or is at risk of worsening during study