Premature Infants Clinical Trial
Official title:
Effects of Automated Adjustment of the Inspired Oxygen in Reducing the Risk of Regional Cerebral (rSO2) Hypo-oxygenation in Preterm Infants on Non Invasive or Invasive Respiratory Support
Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo
intensive care is an important risk factor for risk of neurodevelopmental impairment. Near
infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation.
Automated Fraction of Inspired Oxygen (FiO2) adjustment can maintain arterial oxygen
saturation (SpO2) within a target range and may reduce risk of fluctuation of cerebral
oxygenation.
Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2
within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to
SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with
supplemental oxygen.
Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo
intensive care is an important risk factor for risk of neurodevelopmental impairment. Near
infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation.
Automated FiO2 adjustment can maintain arterial oxygen saturation (SpO2) within a target
range and may reduce risk of fluctuation of cerebral oxygenation.
Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2
within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to
SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with
supplemental oxygen.
Methodology: multicenter randomized cross-over clinical trial. The study will be carried out
for almost 1 year .
Study centers: 7 Italian Neonatal Intensive Care Units (NICUs) Number of subjects: 60
infants to have a >90% power, with an alpha of p=0.01, of detecting a 5% difference in
%-time in the target range and a 50% difference in both SpO2 hyperoxic and hypoxic %-time.
Diagnosis and main inclusion criteria: preterm infants of 25+0-28+6 weeks of gestational
age, requiring invasive or non invasive respiratory support and supplemental oxygen.
Other enrollment requirements: All infants will be enrolled between >72 hours (end of
transition period) and </= 7 days. Expected to remain of the current mode of support for the
48-hour intervention period. Infants with major congenital anomalies, haemodynamic
instability (patent ductus arteriosus-PDA) or requiring catecholamines treatment, clinical
evidence of seizures or ongoing sepsis (positive blood culture) during the study, or within
24 hours prior of enrollment, will be excluded.
Study product:AVEA ventilator with closed-loop inspired oxygen control (CLiO2) automated
FiO2 control option. An additional sensor will be attached to the infant's forehead for
continuous measurement of cerebral tissue oxygen saturation (rStO2) with 5100C NIRS
oximeter, Covidien.
Duration:24 hours each of manual control and CLiO2 control. Reference therapy:Manual control
of FiO2 provided according to standardized guidelines.
Statistical Methodology: repeated measures mixed linear model with control from sequence and
ventilation mode.
Concurrent safety oversight:Independent Data Safety Monitoring Board, with blinded review
every 6 months or 50% enrollment, and after 15 subjects.
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