About this trial
Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored.
Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner.
With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth
Disqualifiers
Preterm infants above 31 weeks completed gestation or term born infants
Infants with major congenital abnormalities
Trial design
Parallel
Treatments tested in this trial
Closed-loop automated oxygen control (Oxygenie, SLE 6000)
DeviceThe OxyGenie closed-loop oxygen saturation monitoring software (SLE) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.
Treatment groups
Trial outcomes
Primary outcomes
The duration of mechanical ventilation
The duration of mechanical ventilation will be measured in median (interquartile range) number of days of ventilation for participants in each group.
Secondary outcomes
The percentage of time spent within target oxygen saturation range.
Target oxygen saturation range for our preterm population is 90-95% as per local guideline. The time spent in target range will be calculated as a percentage of the total time of monitoring.
Number of manual adjustments to the inspired oxygen concentration required by clinical staff.
The number of manual adjustment will be calculated by reviewing the infant's medical records.
Number of days on oxygen.
The number of days each participant will require supplementary oxygen to maintain oxygen saturation levels within target range.
Length of Intensive Care stay
The days each participant is admitted at the Neonatal Intensive Care
Sponsors and contacts
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King's College Hospital NHS Trust
Lead sponsor
King's College London
Collaborator