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Completed

NCT Number: NCT03983694

Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates

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.

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Key information

Conditions

Cerebral Haemodynamics Erythrocyte Transfusion

Age range

0 week–4 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

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.

Primary outcomes

  1. Cerebral metabolic rate of oxygen index (CMRO2i)

    Time frame: From immediately before to immediately after RBC transfusion

    The change in an index proportional to CMRO2

Secondary outcomes

  1. Tissue oxygen saturation (rStO2)

    Time frame: From immediately before to immediately after RBC transfusion

    The change in oxygenated haemoglobin/total haemoglobin

  2. Cerebral blood flow index (CBFi)

    Time frame: From immediately before to immediately after RBC transfusion

    The change in an index proportional to CBF

  3. Differential path length factor (DPF)

    Time frame: From immediately before to immediately after RBC transfusion

    The change in an optical parameter for physiological measurement using NIRS

Sponsors and collaborators

Lead sponsor

Gorm Greisen

Other

Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2019
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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