NCT03983694|CompletedDMC
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Sponsor study identifier
observational
18
1 country
1
Study Start
June 20, 2019
Actual (reported)Primary Completion
July 31, 2022
Actual (reported)Study Completion
December 20, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 7, 2019
Actual (reported)June 12, 2019
Actual (reported)June 20, 2019
Actual (reported)July 31, 2022
Actual (reported)December 20, 2022
Actual (reported)Cerebral metabolic rate of oxygen index (CMRO2i)
The change in an index proportional to CMRO2
From immediately before to immediately after RBC transfusion
Tissue oxygen saturation (rStO2)
From immediately before to immediately after RBC transfusion
Cerebral blood flow index (CBFi)
From immediately before to immediately after RBC transfusion
Differential path length factor (DPF)
From immediately before to immediately after RBC transfusion
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Newborn infants admitted to a neonatal intensive care unit and who need an erythrocyte transfusion
Fondazione IRCCS Ca' Granda
Milan, 20122, Italy
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.
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.
18 participants (actual enrollment reported by the registry).
First Submitted
June 7, 2019
First Posted
June 12, 2019
Study Start
June 20, 2019
Actual (reported)The Effect of Retrograde Autologous Priming on Transfusion Requirements After Cardiac Surgery
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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.
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.
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.
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.
Primary Completion
July 31, 2022
Actual (reported)Study Completion
December 20, 2022
Actual (reported)Last Updated
March 28, 2023
Record last verified: 2023-03
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