Near-Infrared Spectroscopy and Cranial Doppler in Premature Newborns With Anemia

August 8, 2020 updated by: H. Tolga Çelik, Hacettepe University

Comparison of Results of Near-Infrared Spectroscopy and Cranial Doppler Measurements in Premature Newborns With Anemia

It is aimed in this study to examine the changes in brain blood supply and oxygenation in neonatal premature babies who have anemia and who underwent erythrocyte suspension transfusion in the light of original guidelines by means of obtaining measurements with the help of cranial doppler ultrasonography and near-infrared spectroscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Anemia in newborn babies is defined as the mean of hemoglobin values according to postnatal age is below 2 standard deviations. Disruption in tissue perfusion and oxygenation, hyperdynamic cardiac failure, increase in need of oxygen, increase in respiratory effort, inability to be separated from mechanical ventilation, failure to thrive, paleness, increase in frequency of morbidities of prematurity (necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage, etc.) may be seen as a result of progressive anemia. When critical hemoglobin values are reached in premature newborn babies with concomitant disruption of tissue oxygenation, transfusion is performed with erythrocyte suspensions. The main goal here is to correct impaired tissue oxygenation, provide perfusion in sufficient quantity, and prevent anemia-related morbidities. Although frequently applied, there is no consensus in our country and in the world regarding threshold hemoglobin values and supporting parameters for transfusions. As a result, there are no guidelines prepared for newborns based on evidence with clearly defined borders and accepted by everyone. Many countries and centers implement different transfusion protocols based on their experience. Given the risk of oxygen radical damage and associated diseases as a result of erythrocyte transfusions (infections, bone marrow suppression, necrotizing enterocolitis, retinopathy of prematurity, etc.), there is a need to develop new methods for taking and supporting transfusion decision, and to prepare more objective and more accepted guidelines. The origin of our study is the subsequent protective compensation mechanisms after deterioration in brain oxygenation due to symptomatic anemia in premature newborn babies. For these reasons, it is aimed to examine the changes in brain blood supply and oxygenation in neonatal premature babies who have anemia and who underwent erythrocyte suspension transfusion in the light of original guidelines by means of obtaining measurements with the help of cranial doppler ultrasonography and near-infrared spectroscopy.

Study Type

Observational

Enrollment (Anticipated)

100

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

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University
        • Principal Investigator:
          • Ercan Ayaz
        • Principal Investigator:
          • Nursun Özcan

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 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Premature babies in the first 28 postnatal days of life, with less than 32 gestational weeks or less than 1500 grams of birth weight, with documented anemia by current accepted transfusion guidelines of Turkish Neonatal Society

Description

Inclusion Criteria:

Premature babies less than 32 gestational weeks or less than 1500 grams of birth weight and Documented anemia in postnatal 28 days according to Turkish Neonatal Society guidelines

Exclusion Criteria:

Babies older than postnatal 28 days Major congenital anomalies Chromosomal anomalies Inborn errors of metabolism Hypoxic ischemic encephalopathy Disseminated intravascular coagulation Unstable hemodynamic status Severe neonatal sepsis Patients who are not volunteered to participate

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
Study Group
Premature babies in the first 28 postnatal days of life, with less than 32 gestational weeks or less than 1500 grams of birth weight, with documented anemia by current accepted transfusion guidelines of Turkish Neonatal Society
Device: Cranial Doppler Ultrasonography
Before and after the transfusions, flow measurements of middle cerebral arteries will be obtained.
Device: Near-Infrared Spectroscopy
Before, during and after the transfusions, regional cerebral oxygen saturation measurements will be obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gradual improvement in middle cerebral artery flow patterns obtained by cranial doppler ultrasound imaging
Time Frame: Cranial doppler ultrasonography measurements will be obtained immediately before and 4 hours after the trasfusions.
After a critical point, the cerebral oxygenation will be compromised due to anemia in spite of normal compensation mechanisms of cerebral vasculature. Erythrocyte suspension transfusion will help to normalize altered cerebral blood flow. It is hypothesized that these changes can be detected by cranial doppler ultrasonography as follows: Middle cerebral artery peak systolic velocity and flow volume will be increased before transfusion, possibly indicating the need of intervention. Four hours after transfusion, middle cerebral artery peak systolic velocity and flow volume will gradually fall and reach eventually a steady normal state. This in turn may also serve to better understand the effectiveness of the transfusion.
Cranial doppler ultrasonography measurements will be obtained immediately before and 4 hours after the trasfusions.
Gradual improvement in regional cerebral oxygen saturation measures obtained by near-infrared spectroscopy (NIRS)
Time Frame: NIRS measurements will be obtained 4 hours before, 2 hours during, and 4 hours after the trasfusions.
After a critical point, the cerebral oxygenation will be compromised due to anemia in spite of normal compensation mechanisms of cerebral vasculature. Erythrocyte suspension transfusion will help to normalize altered cerebral blood flow. It is hypothesized that these changes can be measured by near-infrared spectroscopy (NIRS) as follows: Regional cerebral oxygen saturations (cSO2) will be low before transfusion, possibly indicating the need of intervention. During transfusion time of 2 hours, cSO2 will rise gradually and reach eventually a steady normal state in 4 hours after transfusion. This in turn may also serve to better understand the effectiveness of the transfusion.
NIRS measurements will be obtained 4 hours before, 2 hours during, and 4 hours after the trasfusions.

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Ercan Ayaz, Hacettepe University
  • Principal Investigator: Nursun Özcan, Hacettepe University

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

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)

March 14, 2019

Primary Completion (Anticipated)

June 23, 2021

Study Completion (Anticipated)

June 23, 2021

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 8, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-19030

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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