NeO2Matic-Pilot Trial

Launched by RIGSHOSPITALET, DENMARK · Nov 23, 2022

Keywords

ClinConnect Summary

The NeO2Matic-Pilot Trial is a study designed to see if using an automated system to adjust the amount of oxygen given to preterm infants helps keep their blood oxygen levels more stable than the traditional method of nurses making these adjustments. This is especially important for newborns who may struggle with breathing and have conditions like respiratory distress syndrome or bronchopulmonary dysplasia.

To be eligible for this trial, newborns need to be receiving a specific type of oxygen support called high-flow nasal therapy and require oxygen levels to be adjusted frequently. However, infants with serious health issues, such as major birth defects or those who are very unstable, won't be included in the study. If a baby takes part, they will be monitored for 48 hours while researchers look at how well the automated oxygen adjustment works compared to the usual care. This study is still in the planning stages and is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newborn infants receiving nHFT via Optiflow 4-8 l/min and FiO2\>0.25, requiring adjustments of FiO2 beyond the extra need during care procedures
• • Likely to be maintained on nHFT during study period of 48 hrs
• Exclusion Criteria:
• • major congenital abnormalities
• • hemodynamic instability including large PDA with right to left shunting
• • clinician's concern regarding infant stability.
• • Unstable infants with frequent apneas, predominantly having need for oxygen during apneic events