Multicenter study of the performance of Fabian-PRICO for saturation targeting routine use in the NICU

During their stay in the neonatal intensive care unit (NICU) nearly all infants
require supplemental oxygen and some form of respiratory support. The
supplemental oxygen ranges between 100% and mostly room air (i.e., requiring
brief low levels of supplemental oxygen administration to address short apneic
spells). The fraction of inspired oxygen (FiO2) is usually titrated manually on
the basis of the peripheral oxygen saturation (SpO2) measured with pulse
oximetry. In addition to targeting normoxemia, avoiding both hypoxemia and
hyperoxemia are important goals during oxygen supplementation as these
conditions are associated respectively with an increased risk of mortality and
with morbidities including retinopathy of prematurity (ROP) and
bronchopulmonary dysplasia (BPD) [2], [3]. However, SpO2 control during routine
care by manually adjusting the FiO2 is a challenging task that is often not
successful. In fact, infants receiving supplemental oxygen spend approximately
50% of the time within, 30% of the time above, and 20% of the time below the
intended SpO2 range [4], [5]. With the purpose of improving oxygen targeting, a
Closed-Loop FiO2-SpO2 controller was developed for adjustment of FiO2 in
response to changes in SpO2 and has been incorporated into the fabian
ventilators. In this study this closed-loop algorithm (PRICO) is investigated
in routine clinical use.

Investigate whether, in a routine clinical environment across a number of
centers, the fabian-PRICO can adequately maintain oxygen saturation, with
minimal staff intervention.

Randomized, cross-over study

This study will compare automated FiO2 control provided by PRICO to manual
control of FiO2. Study subjects will be randomly assigned to both study arms
for 24 hours.

Both investigational interventions can be used as a standard practice in
neonatal units. Therefore, the study is not expected to expose the subject to
any significant risks. However, use of both methods of FiO2 control, might not
be optimal for that subject at that time in their course of treatment. The risk
of this is minimized in that, if such a problem were perceived, the care team
attending the infant or the parent can request withdrawal from the study.

PRICO has the potential to improve the time a patient*s SpO2 values are within
the target range and avoid both hypoxemia and hyperoxemia compared to manually
adjustments of FiO2. Previous research showed that PRICO decreased SpO2
fluctuations and limited the duration of both hypoxemia and hyperoxemia. The
investigation may provide information that will enhance the selection of
optimal oxygen control and thus could improve the effectiveness of subject*s
respiratory care following intervention. The results of the study are expected
to improve respiratory care of infants in general. The device used in the
investigation is bearing the CE mark and is used according to its intended use.