An interventional study of Automated FiO2 adjustment in Cerebrovascular Circulation and Premature Infants, sponsored by ASST Fatebenefratelli Sacco. Status unknown at 1 site in Italy. Open to participants aged 72 Hours to 7 Days. Per ClinicalTrials.gov, last updated 2017-04-17.
Sponsored by ASST Fatebenefratelli Sacco · Not applicable, Interventional, and Supportive care
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 215 are open to participants now.
This study's planned enrollment of 60 is above the median of 43 across 882 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →ASST Fatebenefratelli Sacco is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
24 hours in automated FiO2 adjustment to maintain SpO2 within a target range
Device: Automated FiO2 adjustment
24 hours in manual adjustment of FiO2 to maintain SpO2 within a target range
AVEA ventilator according to SpO2 target range delivers an automated FiO2
the burden of hypoxemia on regional cerebral saturation (rStO2) calculated as area under curve (AUC-% second) below the individual median rStO2 range ( defined as +/-5% of the individual rStO2 median of each infant during each period
burden of hypoxemia on rStO2
Time frame: 24 hours
AUC above the individual median rStO2 and time (% of the total recording time) within the SpO2 target range (91-95%)
burden hyperoxemia
Time frame: 24 hours
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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ASST Fatebenefratelli Sacco