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

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ClinicalTrials.gov Identifier: NCT04509375
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
H. Tolga Çelik, Hacettepe University

Brief Summary:
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.

Condition or disease Intervention/treatment
Anemia of Prematurity Device: Cranial Doppler Ultrasonography Device: Near-Infrared Spectroscopy

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Results of Near-Infrared Spectroscopy and Cranial Doppler Measurements in Premature Newborns With Anemia
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : June 23, 2021
Estimated Study Completion Date : June 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Ultrasound

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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509375


Contacts
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Contact: Hasan Tolga Çelik +90 530 592 55 84 htcelik@gmail.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey
Contact: Hasan Tolga Çelik    +90 530 592 55 84    htcelik@gmail.com   
Principal Investigator: Alper Aykanat         
Principal Investigator: Ercan Ayaz         
Principal Investigator: Nursun Özcan         
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Alper Aykanat Hacettepe University
Principal Investigator: Ercan Ayaz Hacettepe University
Principal Investigator: Nursun Özcan Hacettepe University
Publications:
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Responsible Party: H. Tolga Çelik, Associate Professor of Neonatology, Hacettepe University
ClinicalTrials.gov Identifier: NCT04509375    
Other Study ID Numbers: KA-19030
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Tolga Çelik, Hacettepe University:
Newborn
Anemia
Near-infrared spectroscopy
Cranial doppler ultrasonography
Additional relevant MeSH terms:
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Premature Birth
Anemia
Hematologic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications