Hypotension and ShockNOAHNCT04538079
Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates
An observational study of Hypotension and Shock and Hypoperfusion, run by University College Cork at 1 site in Ireland.
Trial summary
Study type: Prospective Observational trial Study design: Longitudinal Population: Preterm newborns <32 weeks gestational age Hypothesis: The inclusion of non-invasive physiological measures of cardiac output, peripheral perfusion and brain oxygenation (NIRS) for preterm neonates is feasible and reveals additional… Read more about this study
- Who is it for?
- Ages 1 minute to 20 hours
- Conditions the study is for
- Hypotension and Shock, Hypoperfusion, Hemodynamic Instability
- What is being tested?
- Multimodal objective non-invasive Monitoring
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteIreland
- Study dates
- 9 Nov 2019to 31 May 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 minute to 20 hours
- All sexes
- Child
Study population: Preterm Neonates born at a gestational age of 23 weeks 0 days to 31 weeks 6 days.
Who may be able to join
- Neonates of 23 weeks 0 days to 31 weeks 6 days
- NIRS/non-invasive Cardiac Output - device available
- Parental Informed Consent
Who cannot join
- Congenital anomalies
- Major cardiac defects
- Hydrops
- Parents decline to consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates - the NOAH Study
Study type: Prospective Observational trial Study design: Longitudinal Population: Preterm newborns <32 weeks gestational age Hypothesis: The inclusion of non-invasive physiological measures of cardiac output, peripheral perfusion and brain oxygenation (NIRS) for preterm neonates is feasible and reveals additional information on the hemodynamic status compared to blood pressure alone. These measurements can improve the ability to rapidly identify those infants who might benefit from intervention and are correlated with short term clinical outcomes.
Read the detailed description
Understanding neonatal hemodynamics is key to neonatal care. Despite decades of research, uncertainty continues as to how best assess impaired hemodynamics.
Hypotension defined by a low Mean Arterial Blood Pressure (MABP) remains a common issue in preterm infants, affecting up to 30% of extremely preterm infants.
It is common to focus only on MABP thus neglecting the complex and dynamic (patho)physiology that may be present in newborn infants. Providing sufficient cellular oxygenation is the primary task of the circulatory system and different factors may compromise it. In this prospective observational study the investigators will examine various forms of objective non-invasive continuous hemodynamic monitoring methods in very preterm infants
- For feasibility of non-invasive CO measurement (first 20 patients)
- For reproducibility and correlation of this measurement and ECHOcardiography (first 40 echocardiographic examinations)
- For prediction of therapy response.
- For correlation with clinical definitions of hypotension/hypoperfusion
- For prediction of later clinical problems/complications of prematurity and impaired hemodynamic status.
- Conditions
- Hypotension and Shock, Hypoperfusion, Hemodynamic Instability, Intraventricular Hemorrhage, Cardiac Function, Circulatory Transition
- Being tested
- Multimodal objective non-invasive Monitoring
- Keywords
- objective hemodynamic multimodal Monitoring, premature preterm infant
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal objective non-invasive MonitoringDevice
Multimodal objective non-invasive monitoring including cerebral oxygenation (NIRS), pulse oximetry with Pulsatility Index (PI) and non-invasive Cardiac Output Monitoring will be recorded but not used for clinical decision making. 2 ECHOs will be performed (one within the first 24h, one in the 2nd 24 hours after birth)
| Study group | Role | What they receive |
|---|---|---|
| Feasibility/Accuracy/Reproducibility | The first 20 participants will be analysed for feasibility and the first 40 ECHOs for accuracy/reproducibility of non-invasive Cardiac Output Monitoring with ECHO as reference Method. Receives: Device: Multimodal objective non-invasive Monitoring | |
| Prediction of Circulatory Failure | Together with the Feasibility/Accuracy/Reproducibility Cohort this group's results will be analysed for prediction of circulatory failure defined as an ultrasound abnormality (IVH grade 3 - 4) or death within the first two weeks of life. Receives: Device: Multimodal objective non-invasive Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Outcome of Circulatory Failure
Correlation of clinical, laboratory, conventional and multimodal non-invasive monitoring and/or a combination of variables with ultrasound abnormality (IVH grade 3 - 4/any IVH) or death within the first two weeks of life.
Measured: 14 days
Secondary outcomes (14)
Feasibility of non-invasive Cardiac Output Monitoring and Pulsatility Index
The proportion of infants in whom a continuous recording of non-invasive cardiac output (CO) and perfusion index (PI) analysis was obtained for at least 24 hours during the first 48 hours after birth with a good signal quality index
Measured: 48 hours
Reproducibility of absolute left ventricular cardiac output estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
Reproducibility of cardiac output estimates by non-invasive Cardiac Output compared to echocardiographic examinations will be performed using absolute left ventricular output [mL/min]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
Measured: 48 hours
Reproducibility of left ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
Reproducibility of cardiac output estimates by non-invasive Cardiac Output compared to echocardiographic examinations will be performed using left ventricular output indexed to bodyweight [mL/kg bodyweight/min]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
Measured: 48 hours
Reproducibility of left ventricular stroke volume estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
Reproducibility of left ventricular stroke volume estimates by non-invasive Cardiac Output compared to echocardiographic examinations will be performed using stroke volume [mL]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
Measured: 48 hours
Reproducibility of absolute right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
Reproducibility of absolute cardiac output estimated by non-invasive Cardiac Output Monitoring compared to echocardiographic examinations will be performed using right ventricular output [mL/min]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
Measured: 48 hours
Reproducibility of right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to estimation by non-invasive Cardiac Output Monitoring
Reproducibility of relative right ventricular cardiac output estimates by non-invasive Cardiac Output Monitoring compared to echocardiographic examinations will be performed using right ventricular output indexed to bodyweight [mL/kg bodyweight/min]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
Measured: 48 hours
Reproducibility of left ventricular systolic time interval ratio estimated by non-invasive Cardiac Output Monitoring compared to echocardiography
Reproducibility of left ventricular systolic time interval ratio estimates by non-invasive Cardiac Output-Monitoring and echocardiographic examinations will be compared using left ventricular pre-ejection period to left ventricular output time ratio [no unit]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
Measured: 48 hours
Reproducibility of absolute superior vena cava flow estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography
Cardiac output estimates of non-invasive Cardiac Output-Monitoring and echocardiographic examinations will be compared using absolute superior vena cava flow [mL/min]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
Measured: 48 hours
Reproducibility of superior vena cava flow indexed to bodyweight estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography
Cardiac output estimates of non-invasive Cardiac Output-Monitoring and echocardiographic examinations will be compared using superior vena cava flow indexed to bodyweight [mL/kg bodyweight/min]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
Measured: 48 hours
Correlation of non-invasive Cardiac Output Monitoring with echocardiography
CO-Monitoring and echocardiography will be analysed for correlation using correlation coefficient analysis pairwise for left and right ventricular output indexed to bodyweight [mL/kg bodyweight/min], left ventricular pre-ejection period to left ventricular output time ratio and Superior Vena Cava-flow indexed to bodyweight [mL/kg bodyweight/min].
Measured: 48 hours
Prediction of response to volume/red-blood cell transfusion by Corrected Flow Time estimated with non-invasive Cardiac Output Monitoring
Treatment Responsiveness (Volume and/or red blood cells responsiveness) using trend analysis within Corrected Flow Time (FTC [ms]) for volume responsiveness including a receiver operating characteristic analysis for infants who received volume and/or red blood cells during the study period. (Comparison of 20min mean as baseline before, during and 20min after treatment. Response is defined as normalization of the above mentioned physiological parameters within 20 minutes after receiving treatment.
Measured: 48 hours
Prediction of response to volume/red-blood cell transfusion by St roke Volume Variation estimated with non-invasive Cardiac Output Monitoring
Treatment Responsiveness (Volume and/or red blood cells responsiveness) using trend analysis within Stroke Volume Variation (SVV) for volume responsiveness including a receiver operating characteristic analysis for infants who received volume and/or red blood cells during the study period. (Comparison of 20min mean as baseline before, during and 20min after treatment. Response is defined as normalization of the above mentioned physiological parameters within 20 minutes after receiving treatment.
Measured: 48 hours
Prediction of Prediction of response to inotropes by non-invasive Cardiac Output Monitoring response to therapy by non-invasive Cardiac Output Monitoring
Treatment Responsiveness (Inotrope) using trend analysis within left ventricular cardiac output indexed to bodyweight [ml/kg bodyweight/min] for inotrope responsiveness including a receiver operating characteristic analysis for infants who received inotropes during the study period. (Comparison of 20min mean as baseline before, during and 20min after initiation of inotrope treatment. Response is defined as normalization of the above mentioned physiological parameters within 20 minutes after receiving treatment.
Measured: 48 hours
Correlation with definitions of hypotension
Correlation of multimodal non-invasive monitoring with commonly used definitions of hypotension (Mean Arterial Blood Pressure MABP below 30mmHG and/or MABP below gestational age in weeks)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start9 Nov 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Why it stopped: End of funding period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension and ShockStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gene Dempsey, University College Cork
- Investigators
- Eugene M Dempsey, MD, Principal investigator, UCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538079
- Sponsor's protocol ID
- ED001/19UCC
- Acronym
- NOAH
- Status last verified
- Jan 2023
- First submitted
- 5 Mar 2020
- Last updated
- 27 Jan 2023
- 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 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates - the NOAH Study
- ClinicalTrials.gov ID
- NCT04538079
- Acronym / sponsor ID
- NOAH / ED001/19UCC
- Conditions
- Hypotension and Shock, Hypoperfusion, Hemodynamic Instability, Intraventricular Hemorrhage, Cardiac Function, Circulatory Transition
- Keywords
- objective hemodynamic multimodal Monitoring, premature preterm infant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: End of funding period
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 9 Nov 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 3 Sep 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.
Study type: Prospective Observational trial Study design: Longitudinal Population: Preterm newborns <32 weeks gestational age Hypothesis: The inclusion of non-invasive physiological measures of cardiac output, peripheral perfusion and brain oxygenation (NIRS) for preterm neonates is feasible and reveals additional information on the hemodynamic status compared to blood pressure alone. These measurements can improve the ability to rapidly identify those infants who might benefit from intervention and are correlated with short term clinical outcomes.
Detailed description
Understanding neonatal hemodynamics is key to neonatal care. Despite decades of research, uncertainty continues as to how best assess impaired hemodynamics.
Hypotension defined by a low Mean Arterial Blood Pressure (MABP) remains a common issue in preterm infants, affecting up to 30% of extremely preterm infants.
It is common to focus only on MABP thus neglecting the complex and dynamic (patho)physiology that may be present in newborn infants. Providing sufficient cellular oxygenation is the primary task of the circulatory system and different factors may compromise it. In this prospective observational study the investigators will examine various forms of objective non-invasive continuous hemodynamic monitoring methods in very preterm infants
- For feasibility of non-invasive CO measurement (first 20 patients)
- For reproducibility and correlation of this measurement and ECHOcardiography (first 40 echocardiographic examinations)
- For prediction of therapy response.
- For correlation with clinical definitions of hypotension/hypoperfusion
- For prediction of later clinical problems/complications of prematurity and impaired hemodynamic status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feasibility/Accuracy/Reproducibility | – | Device: Multimodal objective non-invasive MonitoringThe first 20 participants will be analysed for feasibility and the first 40 ECHOs for accuracy/reproducibility of non-invasive Cardiac Output Monitoring with ECHO as reference Method. |
| Prediction of Circulatory Failure | – | Device: Multimodal objective non-invasive MonitoringTogether with the Feasibility/Accuracy/Reproducibility Cohort this group's results will be analysed for prediction of circulatory failure defined as an ultrasound abnormality (IVH grade 3 - 4) or death within the first two weeks of life. |
Who may qualify
- Ages
- 1 minute to 20 hours
- Sex
- All
- Age groups
- Child
- Study population
- Preterm Neonates born at a gestational age of 23 weeks 0 days to 31 weeks 6 days.
Key inclusion criteria (3 listed)
- Neonates of 23 weeks 0 days to 31 weeks 6 days
- NIRS/non-invasive Cardiac Output - device available
- Parental Informed Consent
Key exclusion criteria (4 listed)
- Congenital anomalies
- Major cardiac defects
- Hydrops
- Parents decline to consent to the study
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 |
|---|---|---|
| Multimodal objective non-invasive MonitoringMultimodal objective non-invasive monitoring including cerebral oxygenation (NIRS), pulse oximetry with Pulsatility Index (PI) and non-invasive Cardiac Output Monitoring will be recorded but not used for clinical decision making. 2 ECHOs will be performed (one within the first 24h, one in the 2nd 24 hours after birth) | Device | Feasibility/Accuracy/Reproducibility, Prediction of Circulatory Failure |
Primary outcome
Adverse Outcome of Circulatory Failure
Time frame: 14 days
Correlation of clinical, laboratory, conventional and multimodal non-invasive monitoring and/or a combination of variables with ultrasound abnormality (IVH grade 3 - 4/any IVH) or death within the first two weeks of life.
14 secondary outcomes
Feasibility of non-invasive Cardiac Output Monitoring and Pulsatility Index
Time frame: 48 hours
Reproducibility of absolute left ventricular cardiac output estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
Time frame: 48 hours
Reproducibility of left ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
Time frame: 48 hours
Reproducibility of left ventricular stroke volume estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
Time frame: 48 hours
Reproducibility of absolute right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
Time frame: 48 hours
Reproducibility of right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to estimation by non-invasive Cardiac Output Monitoring
Time frame: 48 hours
Reproducibility of left ventricular systolic time interval ratio estimated by non-invasive Cardiac Output Monitoring compared to echocardiography
Time frame: 48 hours
Reproducibility of absolute superior vena cava flow estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography
Time frame: 48 hours
Reproducibility of superior vena cava flow indexed to bodyweight estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography
Time frame: 48 hours
Correlation of non-invasive Cardiac Output Monitoring with echocardiography
Time frame: 48 hours
Prediction of response to volume/red-blood cell transfusion by Corrected Flow Time estimated with non-invasive Cardiac Output Monitoring
Time frame: 48 hours
Prediction of response to volume/red-blood cell transfusion by St roke Volume Variation estimated with non-invasive Cardiac Output Monitoring
Time frame: 48 hours
Prediction of Prediction of response to inotropes by non-invasive Cardiac Output Monitoring response to therapy by non-invasive Cardiac Output Monitoring
Time frame: 48 hours
Correlation with definitions of hypotension
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: End of funding period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Eugene M Dempsey, MD principal investigator
UCC
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 Hypotension and Shock and Hypoperfusion, run by University College Cork at 1 site in Ireland.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 27 Jan 2023. 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 Ireland. 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 was stopped early (reason given: End of funding period). Results are not available in the source record.
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?
Adverse Outcome of Circulatory Failure (time frame: 14 days). 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 27 Jan 2023.