Cerebral AutoregulationNCT04423016
Transitional Cerebrovascular Reactivity in Very Preterm Infants
An observational study of Cerebral Autoregulation and Preterm Birth, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant clinical implications. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Cerebral Autoregulation, Preterm Birth, Premature Infant Disease
- What is being tested?
- Near Infrared Spectroscopy monitoring and Electrical velocimetry and pulse oximetry
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2018to 3 Jul 2021
- Phase
- Observational
- 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 1 day to 3 days
- All sexes
- Child
Study population: Preterm infants <32 weeks' gestation during the transitional period (0-72 hours of life)
Who may be able to join
- gestational age <32 weeks' gestation
Who cannot join
- major congenital malformations
- congenital heart disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
Sant'Orsola-Malpighi University Hospital
Bologna, Emilia-Romagna, 40138
About this study
Official title: Clinical Determinants of Cerebrovascular Reactivity in Very Preterm Infants During the Transitional Period
The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant clinical implications. The moving correlation coefficient between cerebral oxygenation and heart rate, also defined as TOHRx, has been previously proposed as a marker of cerebrovascular reactivity and provides an indirect estimation of cerebral autoregulation in preterm infants.
This study aims to evaluate whether different antenatal, perinatal and postnatal factors may influence cerebrovascular reactivity in very preterm infants during the transitional period.
Read the detailed description
The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant clinical implications. The moving correlation coefficient between cerebral oxygenation and heart rate, also defined as TOHRx, has been previously proposed as a marker of cerebrovascular reactivity and provides an indirect estimation of cerebral autoregulation in preterm infants.
This prospective observational study aims to evaluate whether different antenatal, perinatal, and postnatal factors may influence cerebrovascular reactivity in very preterm infants during the transitional period.
Infants <32 weeks' gestation are enrolled within 12h from birth. A simultaneous monitoring of cerebral oxygenation (CrSO2) by near-infrared spectroscopy and of heart rate (HR) by pulse oximetry and electrical velocimetry is performed continuously over the first 72h.
The moving correlation coefficient between CrSO2 and HR is calculated using the ICM+ software (Cambridge Enterprise Ltd) using 5-min, 30-point epochs. Time periods with evidence of major artefacts, or with a missing data proportion >50% are excluded from this calculation. Positive TOHRx values will be interpreted as markers of impaired autoregulation.
A screening echocardiogram is routinely performed at the time of enrollment and repeated 6-12 hourly in the presence of a patent ductus arteriosus (PDA) or 12-24 hourly if there is no evidence of PDA. Based on echocardiographic features, the ductal status is classified as follows: no evidence of PDA, restrictive PDA (restrictive shunt pattern and left atrium to aortic root ratio [LA:Ao] ratio <1.5), hemodynamically significant PDA (pulsatile shunt pattern, LA:Ao ratio ≥1.5 or presence of reversed end-diastolic flow either in the descending aorta or in the anterior cerebral artery).
A concomitant cerebral ultrasound scan, aimed at evaluating brain parenchyma and the occurrence of prematurity-related complications, such as intraventricular hemorrhage, is also performed.
During the study period, the following antenatal and neonatal data are tracked down on a specific case report form: gestational age (GA); birth weight (BW); non-invasive blood pressure; antenatal steroids (complete course vs. incomplete course or not given); evidence of reversed end-diastolic flow at antenatal umbilical Doppler (uREDF) (present vs. absent); ventilatory status over the first 72 hours of life (mechanical ventilation, continuous positive airway pressure [CPAP], nasal cannulas or self-ventilating in air [SVIA]); surfactant administration; development of IVH over the first 72 hours of life; ongoing inotropes (dopamine, dobutamine or both).
The correlation between antenatal, perinatal, and postnatal clinical variables and TOHRx is going to be evaluated using generalized linear mixed models or generalized estimating equations.
- Being tested
- Near Infrared Spectroscopy monitoring, Electrical velocimetry and pulse oximetry
- Keywords
- cerebral autoregulation, cerebrovascular reactivity, preterm infants, transitional period
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy monitoringDevice
Non-invasive continuous monitoring of cerebral oxygenation
Electrical velocimetry and pulse oximetryDevice
Non-invasive continuous monitoring of cerebral oxygenation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between TOHRx and gestational age
Correlation between TOHRx and gestational age
Measured: 0-72 hours
Correlation between TOHRx and antenatal steroids administration
Correlation between TOHRx and antenatal steroids administration (full course vs. incomplete course or not given)
Measured: 0-72 hours
Correlation between TOHRx and antenatal Doppler status
Correlation between TOHRx and antenatal Doppler status (normal or abnormal)
Measured: 0-72 hours
Correlation between TOHRx and ductal status
Correlation between TOHRx and ductal status (hemodynamically significant, restrictive or closed)
Measured: 0-72 hours
Correlation between TOHRx and respiratory support
Correlation between TOHRx and respiratory support modality (mechanical ventilation, CPAP, nasal cannulas or self-ventilating in air)
Measured: 0-72 hours
Correlation between TOHRx and inotropes
Correlation between TOHRx and inotropes administration (dopamine; dobutamine; dopamine and dobutamine)
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start21 Feb 2018
- Primary completion30 Jun 2021
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AutoregulationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Corvaglia, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Luigi Corvaglia, MD, Principal investigator, S. Orsola-Malpighi University Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423016
- Sponsor's protocol ID
- NEO-TOHRx
- Status last verified
- Jul 2021
- First submitted
- 5 Jun 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Determinants of Cerebrovascular Reactivity in Very Preterm Infants During the Transitional Period
- ClinicalTrials.gov ID
- NCT04423016
- Acronym / sponsor ID
- NEO-TOHRx
- Keywords
- cerebral autoregulation, cerebrovascular reactivity, preterm infants, transitional period
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 3 Jul 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- 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.
The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant clinical implications. The moving correlation coefficient between cerebral oxygenation and heart rate, also defined as TOHRx, has been previously proposed as a marker of cerebrovascular reactivity and provides an indirect estimation of cerebral autoregulation in preterm infants.
This study aims to evaluate whether different antenatal, perinatal and postnatal factors may influence cerebrovascular reactivity in very preterm infants during the transitional period.
Detailed description
The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant clinical implications. The moving correlation coefficient between cerebral oxygenation and heart rate, also defined as TOHRx, has been previously proposed as a marker of cerebrovascular reactivity and provides an indirect estimation of cerebral autoregulation in preterm infants.
This prospective observational study aims to evaluate whether different antenatal, perinatal, and postnatal factors may influence cerebrovascular reactivity in very preterm infants during the transitional period.
Infants <32 weeks' gestation are enrolled within 12h from birth. A simultaneous monitoring of cerebral oxygenation (CrSO2) by near-infrared spectroscopy and of heart rate (HR) by pulse oximetry and electrical velocimetry is performed continuously over the first 72h.
The moving correlation coefficient between CrSO2 and HR is calculated using the ICM+ software (Cambridge Enterprise Ltd) using 5-min, 30-point epochs. Time periods with evidence of major artefacts, or with a missing data proportion >50% are excluded from this calculation. Positive TOHRx values will be interpreted as markers of impaired autoregulation.
A screening echocardiogram is routinely performed at the time of enrollment and repeated 6-12 hourly in the presence of a patent ductus arteriosus (PDA) or 12-24 hourly if there is no evidence of PDA. Based on echocardiographic features, the ductal status is classified as follows: no evidence of PDA, restrictive PDA (restrictive shunt pattern and left atrium to aortic root ratio [LA:Ao] ratio <1.5), hemodynamically significant PDA (pulsatile shunt pattern, LA:Ao ratio ≥1.5 or presence of reversed end-diastolic flow either in the descending aorta or in the anterior cerebral artery).
A concomitant cerebral ultrasound scan, aimed at evaluating brain parenchyma and the occurrence of prematurity-related complications, such as intraventricular hemorrhage, is also performed.
During the study period, the following antenatal and neonatal data are tracked down on a specific case report form: gestational age (GA); birth weight (BW); non-invasive blood pressure; antenatal steroids (complete course vs. incomplete course or not given); evidence of reversed end-diastolic flow at antenatal umbilical Doppler (uREDF) (present vs. absent); ventilatory status over the first 72 hours of life (mechanical ventilation, continuous positive airway pressure [CPAP], nasal cannulas or self-ventilating in air [SVIA]); surfactant administration; development of IVH over the first 72 hours of life; ongoing inotropes (dopamine, dobutamine or both).
The correlation between antenatal, perinatal, and postnatal clinical variables and TOHRx is going to be evaluated using generalized linear mixed models or generalized estimating equations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Age groups
- Child
- Study population
- Preterm infants <32 weeks' gestation during the transitional period (0-72 hours of life)
Key inclusion criteria (1 listed)
- gestational age <32 weeks' gestation
Key exclusion criteria (2 listed)
- major congenital malformations
- congenital heart disease
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 |
|---|---|---|
| Near Infrared Spectroscopy monitoringNon-invasive continuous monitoring of cerebral oxygenation | Device | – |
| Electrical velocimetry and pulse oximetryNon-invasive continuous monitoring of cerebral oxygenation | Device | – |
Primary outcome
Correlation between TOHRx and gestational age
Time frame: 0-72 hours
Correlation between TOHRx and gestational age
Correlation between TOHRx and antenatal steroids administration
Time frame: 0-72 hours
Correlation between TOHRx and antenatal steroids administration (full course vs. incomplete course or not given)
Correlation between TOHRx and antenatal Doppler status
Time frame: 0-72 hours
Correlation between TOHRx and antenatal Doppler status (normal or abnormal)
Correlation between TOHRx and ductal status
Time frame: 0-72 hours
Correlation between TOHRx and ductal status (hemodynamically significant, restrictive or closed)
Correlation between TOHRx and respiratory support
Time frame: 0-72 hours
Correlation between TOHRx and respiratory support modality (mechanical ventilation, CPAP, nasal cannulas or self-ventilating in air)
Correlation between TOHRx and inotropes
Time frame: 0-72 hours
Correlation between TOHRx and inotropes administration (dopamine; dobutamine; dopamine and dobutamine)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Homeostasis
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.
Luigi Corvaglia, MD principal investigator
S. Orsola-Malpighi University Hospital, Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Autoregulation and Preterm Birth, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 2 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: finished, as of the sponsor's last update on 28 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between TOHRx and gestational age (time frame: 0-72 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2021.