Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates

Study Overview
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Brief Summary
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The timing and the indications for red blood cell (RBC) transfusions remain one of the most controversial topic in Neonatology. Indeed, biomarkers routinely used to discriminate between patients that will benefit from RBC transfusion appear insufficient. Tissue oxygenation could be useful to determine the need for transfusion. This study aims to assess the effects of RBC transfusion on cerebral haemodynamics and oxygenation in neonates with a new hybrid optical device (BabyLux) integrating time-resolved spectroscopy (NIRS-TRS) and diffuse correlation spectroscopy (DCS). It is hypothesized that cerebral blood flow decreases after RBC transfusion, whereas cerebral oxygenation and oxygen metabolism are unchanged.

Detailed Description
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The BabyLux hybrid setup can determine the following parameters in the same tissue sample non-invasively and continuously with a high temporal resolution (0.1-0.2 Hz): Cerebral blood flow index (CBFi), i.e. an index that is proportional with CBF Concentration of oxyhaemoglobin (O2Hb) Concentration of deoxyhaemoglobin (dHb) Total haemoglobin concentration (tHb) Tissue oxygen saturation (rStO2) Cerebral metabolic rate of oxygen index (CMRO2i), i.e. an index that is proportional with CMRO2 Hence, the BabyLux device allows assessment of key parameters of cerebral haemodynamics and, in particular, to examine if the percentage change of cerebral metabolic rate for oxygen is close to the expected zero, as an external quality control of the separate NIRS parameters. There are no studies on RBC transfusion in neonates evaluating cerebral haemodynamic utilizing DCS and TRS combined. Hence, primary aim of this study is: - to assess the effect of RBC transfusion on cerebral haemodynamics and oxygenation as measured by the Babylux device. Secondary aims are: to quantify the effect of estimated ∆[Hb] on the differential path length factor (DPF); to compare two different NIRS devices and techniques. BabyLux measurement will be performed before and after RBC transfusion, whereas during RBC transfusion cerebral oxygenation will be monitored with a spatially resolved continuous wave (CW) NIRS.

Official Title
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Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates

Conditions
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Cerebral Haemodynamics, Erythrocyte Transfusion

Intervention / Treatment
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* Other: Erythrocyte transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RBC transfusion prescribed according to local NICU guidelines Corrected age < 4 weeks corrected age Signed informed consent Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 0 Weeks
Maximum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BabyLux device<br>Cerebral haemodynamics of neonates undergoing erythrocyte transfusion according to the local clinical guidelines are monitored with BabyLux device before and after transfusion and with traditional NIRS during itself. | Other: Erythrocyte transfusion<br>* The cerebro-vascular effects of a clinically prescribed erytrocyte (red blood cell) transfusion is examined. Before the transfusion, BabyLux sensor is placed on the neonatal fronto-parietal region and held in place by a self-adhesive bandage. A baseline prior to transfusion is established through a series of five repeated measurements of 1 minute taken during a stable period just before the transfusion is started. Once transfusion has ended, another series of five repeated measurements of 1 minute taken during a stable period are performed to determine the responses. Cerebral oxygenation as determined by a commercial spatially resolved NIRS device with neonatal sensor will be continuously recorded during transfusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral metabolic rate of oxygen index (CMRO2i) | The change in an index proportional to CMRO2 | From immediately before to immediately after RBC transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue oxygen saturation (rStO2) | The change in oxygenated haemoglobin/total haemoglobin | From immediately before to immediately after RBC transfusion | 
| Cerebral blood flow index (CBFi) | The change in an index proportional to CBF | From immediately before to immediately after RBC transfusion | 
| Differential path length factor (DPF) | The change in an optical parameter for physiological measurement using NIRS | From immediately before to immediately after RBC transfusion |