Cerebrovascular CirculationNCT02748447
Automated Adjustment of Inspired Oxygen to Maintaining Regional Cerebral Oxygenation in Preterm Infants on Respiratory Support
A study testing Automated FiO2 adjustment in people with Cerebrovascular Circulation and Premature Infants, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 72 hours to 7 days
- Conditions the study is for
- Cerebrovascular Circulation, Premature Infants
- What is being tested?
- Automated FiO2 adjustment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 hours to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants of 25+0-28+6 weeks of gestational age, requiring invasive or non invasive respiratory support and supplemental oxygen
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
V. Buzzi Childrens's Hospital - ASST FBF-SACCO
Milan, 20154
Ilaria Stucchi, MD, 00390257995341, ilaria.stucchi@asst-fbf-sacco.it
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Circulation, Premature Infants
- Being tested
- Automated FiO2 adjustment
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated FiO2 adjustmentDevice
AVEA ventilator according to SpO2 target range delivers an automated FiO2
| Study group | Role | What they receive |
|---|---|---|
| A-FiO2 | Experimental | 24 hours in automated FiO2 adjustment to maintain SpO2 within a target range Receives: Device: Automated FiO2 adjustment |
| M-FiO2 | No intervention | 24 hours in manual adjustment of FiO2 to maintain SpO2 within a target range |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (1)
AUC above the individual median rStO2 and time (% of the total recording time) within the SpO2 target range (91-95%)
burden hyperoxemia
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Lista,MD, ASST Fatebenefratelli Sacco
- Investigators
- Gianluca Lista, MD, Principal investigator, ASST-FBF-Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748447
- Sponsor's protocol ID
- PoloU
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2016
- Last updated
- 17 Apr 2017
- Results posted
- No
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.
PubMed 19299799Laptook 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.
PubMed 16598294Claure 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.
PubMed 19595375van 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.
PubMed 26144575
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02748447
- Acronym / sponsor ID
- PoloU
- Conditions
- Cerebrovascular Circulation, Premature Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-FiO2 | Experimental | Device: Automated FiO2 adjustment24 hours in automated FiO2 adjustment to maintain SpO2 within a target range |
| M-FiO2 | No intervention | –24 hours in manual adjustment of FiO2 to maintain SpO2 within a target range |
Who may qualify
- Ages
- 72 hours to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm infants of 25+0-28+6 weeks of gestational age, requiring invasive or non invasive respiratory support and supplemental oxygen
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated FiO2 adjustmentAVEA ventilator according to SpO2 target range delivers an automated FiO2 | Device | A-FiO2 |
Primary outcome
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
1 secondary outcome
AUC above the individual median rStO2 and time (% of the total recording time) within the SpO2 target range (91-95%)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Results publication: PubMed 19299799Kurth 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.
- Results publication: PubMed 16598294Laptook 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.
- Results publication: PubMed 19595375Claure 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.
- Results publication: PubMed 26144575van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Lista, MD principal investigator
ASST-FBF-Sacco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated FiO2 adjustment in people with Cerebrovascular Circulation and Premature Infants, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Stucchi, MF (00393358050962, stucchi.ilaria@icp.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748447, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.