Optimal target range of the CLIO2

Both hypoxia and hyperoxia can lead to organ damage in preterm infants. For this reason the
transcutaneously measured oxygen saturation (SpO2) is kept within a range between 86% and
95%. Hypoxia is mainly caused by immature or impaired control of breathing (apnea) and/or
a compromised lung function. Hypoxia is often treated with supplemental oxygen, which is
manually adjusted to keep the SpO2 within the target range. However, due to clinical
instability and the limited time nurses have to adjust the amount of oxygen, preterm infants
only spent approximately 50% of the time within the SpO2 target range. Recent studies have
shown that the automatic fractional inspired oxygen (FiO2) function of the AVEA ventilator is
more capable of maintaining preterm infants within preset saturation ranges than manual
adjustment. However, it is unknown to what extent narrowing the SpO2 target range during
automated control will result in a tighter control of the SpO2.
This randomized controlled cross-over trial will assess the optimal target range of the automatic FiO2 function by maintaining the same mean, and narrowing the upper and lower limits of the target range.

Both hypoxia and hyperoxia can lead to organ damage in preterm infants. For this reason the transcutaneously measured oxygen saturation (SpO2) is kept within a range between 86% and 95%. Hypoxia is mainly caused by immature or impaired control of breathing (apnea) and/or a compromised lung function. Hypoxia is often treated with supplemental oxygen, which is manually adjusted to keep the SpO2 within the target range. However, due to clinical instability and the limited time nurses have to adjust the amount of oxygen, preterm infants only spent approximately 50% of the time within the SpO2 target range. Recent studies have shown that the automatic fractional inspired oxygen (FiO2) function of the AVEA ventilator is more capable of maintaining preterm infants within preset saturation ranges than manual adjustment. However, it is unknown to what extent narrowing the SpO2 target range during automated control will result in a tighter control of the SpO2. The hypothesis of this trial is that narrowing the target range of the automatic FiO2 function by maintaining the same mean, and narrowing the upper and lower limits of the target range, will result in an increased proportion of time within the target ranges.

Not applicable

Infants enrolled in the study will randomly undergo three study periods of 24 hours each by the automatic function in the AVEA ventilator, one with target ranges of SpO2 set to 86% (lower limit (LL)) to 94% (upper limit (UL)), one with target ranges of SpO2 set to 88% LL and 92% UL SpO2, and one with target ranges of SpO2 set to 89% (LL) and 91% (UL). Random assignment to each target range of SpO2 will be done immediately prior to the start
of the study procedures in each enrolled infant. In order to minimize the effect of the previous
assigned target range, the infants will receive 24 hours of standard care switching off the automatic function after the first and second target range during 24 hours as a wash-out period. Infants will remain in the study for a period of 120 hours. At the end of which, they will exit the study.