- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02748447
Automated Adjustment of Inspired Oxygen to Maintaining Regional Cerebral Oxygenation in Preterm Infants on Respiratory Support
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ilaria Stucchi, MF
- Phone Number: 00393358050962
- Email: stucchi.ilaria@icp.mi.it
Study Locations
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-
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Milan, Italy, 20154
- Recruiting
- V. Buzzi Childrens's Hospital - ASST FBF-SACCO
-
Contact:
- Ilaria Stucchi, MD
- Phone Number: 00390257995341
- Email: ilaria.stucchi@asst-fbf-sacco.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- preterm infants of 25+0-28+6 weeks of gestational age, requiring invasive or non invasive respiratory support and supplemental oxygen
Exclusion Criteria:
- infants with major congenital anomalies, haemodinamic instability, or requiring cathecolamines treatment,clinical evidence of seizures or ongoing sepsis (positive blood culture) during the study, or within 24 hours prior enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A-FiO2
24 hours in automated FiO2 adjustment to maintain SpO2 within a target range
|
AVEA ventilator according to SpO2 target range delivers an automated FiO2
|
No Intervention: M-FiO2
24 hours in manual adjustment of FiO2 to maintain SpO2 within a target range
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 24 hours
|
burden of hypoxemia on rStO2
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC above the individual median rStO2 and time (% of the total recording time) within the SpO2 target range (91-95%)
Time Frame: 24 hours
|
burden hyperoxemia
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gianluca Lista, MD, ASST-FBF-Sacco
Publications and helpful links
General Publications
- Kurth CD, McCann JC, Wu J, Miles L, Loepke AW. Cerebral oxygen saturation-time threshold for hypoxic-ischemic injury in piglets. Anesth Analg. 2009 Apr;108(4):1268-77. doi: 10.1213/ane.0b013e318196ac8e.
- Laptook AR, Salhab W, Allen J, Saha S, Walsh M. Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? J Perinatol. 2006 Jun;26(6):337-41. doi: 10.1038/sj.jp.7211500.
- Claure N, D'Ugard C, Bancalari E. Automated adjustment of inspired oxygen in preterm infants with frequent fluctuations in oxygenation: a pilot clinical trial. J Pediatr. 2009 Nov;155(5):640-5.e1-2. doi: 10.1016/j.jpeds.2009.04.057.
- van Kaam AH, Hummler HD, Wilinska M, Swietlinski J, Lal MK, te Pas AB, Lista G, Gupta S, Fajardo CA, Onland W, Waitz M, Warakomska M, Cavigioli F, Bancalari E, Claure N, Bachman TE. Automated versus Manual Oxygen Control with Different Saturation Targets and Modes of Respiratory Support in Preterm Infants. J Pediatr. 2015 Sep;167(3):545-50.e1-2. doi: 10.1016/j.jpeds.2015.06.012. Epub 2015 Jul 2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PoloU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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