NCT03877198

Comparison of Oxygen Controllers in Preterm InfanTs

A Randomized Cross-over Trial in the Effect of Automated Oxygen Control Devices on the Distribution of Oxygen Saturation in Preterm Infants

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 8 Weeks
• Healthy volunteers: Not accepted

Summary

Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.

Detailed description

Both hypoxemia as hyperoxemia can potentially be harmful to premature infants. Oxygen titration during respiratory support is vital to prevent these conditions but is very challenging. In the investigator's neonatal intensive care unit preterm infants routinely receive automatic oxygen titration performed by a controller. The currently used controllers are both proven to be more effective than manual titration, however which of the two controllers is most effective in keeping oxygen saturation within target range remains unclear. This randomized crossover trial tests tests both controllers within every study patient to determine which controller is most effective and thereby would hopefully reduce morbidity associated with hypoxemia and hyperoxemia the most. The primary outcome measure is the proportion of time spent within target range, each controller will be tested for 24 hours within the same study subject. This is excluding a 1-hour wash-out period after a change in ventilator. Eligible infants are randomized to start with either the Oxygenie algorithm or CLiO2 algorithm and will switch to the other study arm after 24 hours of measurement.

Conditions

• Premature Infant
• Respiratory Insufficiency
• Hypoxia
• Hyperoxia

Interventions

Type	Name	Description
DEVICE	Automated oxygen control by the CLiO2 algorithm	Automated oxygen control for 24 hours by the CLiO2 algorithm, preceded by a 1 hour wash-out period
DEVICE	Automated oxygen control by the Oxygenie algorithm	Automated oxygen control for 24 hours by the Oxygenie algorithm, in case of switch in ventilator preceded by a 1-hour wash-out period.

Timeline

• Start date: 2019-02-19
• Primary completion: 2020-02-13
• Completion: 2020-02-13
• First posted: 2019-03-15
• Last updated: 2020-06-09

Locations

1 site across 1 country: Netherlands