Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates

NCT03983694 | Completed DMC

• 1 other identifier: BabyLux transfusion
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Haemodynamics; Erythrocyte Transfusion

Outcome Measures

Primary Outcomes (1)

• Cerebral metabolic rate of oxygen index (CMRO2i)

  The change in an index proportional to CMRO2

  From immediately before to immediately after RBC transfusion

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Other: Erythrocyte transfusion

Interventions

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.

BabyLux device

Eligibility Criteria

• Age: 0 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants admitted to a neonatal intensive care unit and who need an erythrocyte transfusion

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Gorm Greisen: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

Fondazione IRCCS Ca' Granda

Milan, 20122, Italy

Location

Related Publications (6)

• 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.

  PMID: 24797124 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.

  PMID: 16292938 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.

  PMID: 23145971 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.

  PMID: 20099219 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.

  PMID: 20113454 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.

  PMID: 23901886 BACKGROUND

Related Links

• The BabyLux project web-site

MeSH Terms

Interventions

Erythrocyte Transfusion

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: June 20, 2019
• Primary Completion: July 31, 2022
• Study Completion: December 20, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

IT (1)