Preterm infants, hyperoxemia, hypoxia, desaturation, oxygen saturation targets, closed loop inspired oxygen, CLIO.
Conditions
Interventions
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))
Sponsors
Academic Medical Center, Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Preterm infants, born with a gestational age between 23 and 32 weeks, and a weight at study entry between 0.4 to 4 kilograms, needing non-invasive respiratory support by the AVEA ventilator with a supplemental oxygen > 0.21 for more than 18 hours per day.
Exclusion criteria
Exclusion criteria: The eligible preterm infants will not have one of the following exclusion criteria: major congenital anomalies, arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment, culture proven sepsis within 72 hours prior to enrollment, or if the attending physician deems participation in the study is not in the best interest of the infant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is defined as the proportion of time for all three target ranges with SpO2 within the assigned saturation ranges currently used in the clinical setting, being 86%-94%, minus time with SpO2 above the assigned target range while FiO2 is set at 0.21. | — |
Secondary
| Measure | Time frame |
|---|---|
| Several secondary endpoints will be collected and calculated: 1. the proportion of time in between the FiO2 adjustment periods a) hypoxemia defined as SpO2 98% while FiO2 > 0.21 between the different target ranges. 2. the distribution of SpO2 between the three different periods of target ranges of automatic adjustment of FiO2. This will specifically include the comparisons of the 5th, 25th, 50th, 75th, and 95th percentiles. 3. the fraction of inspired oxygen between the three periods of targets ranges of automatic adjustment of FiO2. For this, the mean, standard deviation, median interquartile and hourly-median FiO2 will be calculated over each recording period. 4. the proportion of time with FiO2 at 0.21 between the three periods of target ranges of automatic adjustment of FiO2. 5. the variability of SpO2 between the three periods of target ranges of automatic FiO2 adjustment. This will specifically include the coefficient of variation (Standard deviation divided by the mean) of SpO2 over each recording period. 6. the frequency and duration of episodes with SpO2 below the target range between the three periods of different target ranges of automatic FiO2 adjustment. 7. the proportion of time with SpO2 below the target range between the three periods of of different target ranges of automatic FiO2 adjustment. This will specifically include the proportion of time with SpO2 below the target range, SpO2 0.21 between the three periods of different target ranges of automatic FiO2 adjustment. 10. the oxygen saturation status following pulse oximeter signal drop-out between periods of automatic FiO2 adjustment. The oxygen saturation status will be defined as SpO2 within, above or below the assigned target range for at least 10 seconds within the first minute after drop-out ends (i.e. Initial status) and at least 60 seconds over the first two minutes after the drop-out ends (i.e. Persistent status). 11. the rate of overshoot status following episodes when SpO2 decrease | — |
Contacts
Public ContactW. Onland
Emma Childrens Hospital/AMC Department of Neonatology
Outcome results
None listed