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| Name | Class |
|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
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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.
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):
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BabyLux device | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythrocyte transfusion | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
None
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Newborn infants admitted to a neonatal intensive care unit and who need an erythrocyte transfusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24797124 | Background | Banerjee J, Aladangady N. Biomarkers to decide red blood cell transfusion in newborn infants. Transfusion. 2014 Oct;54(10):2574-82. doi: 10.1111/trf.12670. Epub 2014 May 5. | |
| 16292938 | Background | Cerussi A, Van Woerkom R, Waffarn F, Tromberg B. Noninvasive monitoring of red blood cell transfusion in very low birthweight infants using diffuse optical spectroscopy. J Biomed Opt. 2005 Sep-Oct;10(5):051401. doi: 10.1117/1.2080102. |
| Label | URL |
|---|---|
| The BabyLux project web-site | View source |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| 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 |
| 23145971 | Background | Koyano K, Kusaka T, Nakamura S, Nakamura M, Konishi Y, Miki T, Ueno M, Yasuda S, Okada H, Nishida T, Isobe K, Itoh S. The effect of blood transfusion on cerebral hemodynamics in preterm infants. Transfusion. 2013 Jul;53(7):1459-67. doi: 10.1111/j.1537-2995.2012.03953.x. Epub 2012 Nov 12. |
| 20099219 | Background | Bailey SM, Hendricks-Munoz KD, Wells JT, Mally P. Packed red blood cell transfusion increases regional cerebral and splanchnic tissue oxygen saturation in anemic symptomatic preterm infants. Am J Perinatol. 2010 Jun;27(6):445-53. doi: 10.1055/s-0030-1247598. Epub 2010 Jan 22. |
| 20113454 | Background | Dani C, Pratesi S, Fontanelli G, Barp J, Bertini G. Blood transfusions increase cerebral, splanchnic, and renal oxygenation in anemic preterm infants. Transfusion. 2010 Jun;50(6):1220-6. doi: 10.1111/j.1537-2995.2009.02575.x. Epub 2010 Jan 22. |
| 23901886 | Background | Sandal G, Oguz SS, Erdeve O, Akar M, Uras N, Dilmen U. Assessment of red blood cell transfusion and transfusion duration on cerebral and mesenteric oxygenation using near-infrared spectroscopy in preterm infants with symptomatic anemia. Transfusion. 2014 Apr;54(4):1100-5. doi: 10.1111/trf.12359. Epub 2013 Jul 31. |