Clinical trial NCT03983694: Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates
Official title: Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Haemodynamics
Erythrocyte Transfusion
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2019-06-12
Enrollment: 18
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants admitted to a neonatal intensive care unit and who need an erythrocyte transfusion

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* RBC transfusion prescribed according to local NICU guidelines
* Corrected age \< 4 weeks corrected age
* Signed informed consent

Exclusion Criteria:

None

Primary outcomes:
measure: Cerebral metabolic rate of oxygen index (CMRO2i)
timeFrame: From immediately before to immediately after RBC transfusion
Secondary outcomes:
measure: Tissue oxygen saturation (rStO2)
timeFrame: From immediately before to immediately after RBC transfusion
measure: Cerebral blood flow index (CBFi)
timeFrame: From immediately before to immediately after RBC transfusion
measure: Differential path length factor (DPF)
timeFrame: From immediately before to immediately after RBC transfusion
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.