Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Burden of clinical suspicion indicating Circulatory Insufficiency |
Onset and duration of clinical suspicion of Circulatory Insufficiency in clinical examination (i.e. skin colour, increased capillary refill time>3seconds) as documented in the clinical charts. |
48 hours |
|
Other |
Burden of Laboratory parameters indicating Circulatory Insufficiency |
Onset and duration of circulatory insufficiency indicated by laboratory parameters (metabolic acidosis with pH<7,2 Lactate>3mmol/L not explainable by intrapartum complications) |
48 hours |
|
Other |
Burden and Onset of Hypotension indicating Circulatory Insufficiency |
Time spend with Mean Arterial Blood Pressure (MABP) below 30mmHG and/or MABP below gestational age in weeks |
48 hours |
|
Other |
Burden of Cerebral Oxygenation indicating Circulatory Insufficiency |
Time spend wit cerebral regional tissue Saturation (rcStO2) below a value of 60% and/or rcStO2/fraction of tissue oxygen extraction (rcFtO2E) below the infants median value-5% |
48 hours |
|
Other |
Burden of Low Cardiac Output indicating Circulatory Insufficiency |
Time spend with Cardiac Output in the lower quartile of the Cohort. |
48 hours |
|
Other |
Burden of impaired cerebral Autoregulation |
Time spend with pressure passivity of cerebral regional tissue oxygenation (MABP and or Pulse Pressure to rcStO2/rcFtO2E). Adjusted mutual information and transfer entropy will be used to quantify coupling between MABP or pulse pressure and rcStO2 or rcFtO2E. |
48 hours |
|
Primary |
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. |
14 days |
|
Secondary |
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 |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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]. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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. |
48 hours |
|
Secondary |
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) |
48 hours |
|