Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates

March 27, 2023 updated by: Gorm Greisen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From immediately before to immediately after RBC transfusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue oxygen saturation (rStO2)
Time Frame: From immediately before to immediately after RBC transfusion
The change in oxygenated haemoglobin/total haemoglobin
From immediately before to immediately after RBC transfusion
Cerebral blood flow index (CBFi)
Time Frame: From immediately before to immediately after RBC transfusion
The change in an index proportional to CBF
From immediately before to immediately after RBC transfusion
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
From immediately before to immediately after RBC transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gorm Greisen

Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2019

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 11, 2019

First Posted (Actual)

June 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BabyLux transfusion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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