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
|Condition or disease||Intervention/treatment|
|Anemia of Prematurity||Device: Cranial Doppler Ultrasonography Device: Near-Infrared Spectroscopy|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
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.
- 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.
- 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.
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
|Contact: Hasan Tolga Çelik||+90 530 592 55 email@example.com|
|Contact: Hasan Tolga Çelik +90 530 592 55 84 firstname.lastname@example.org|
|Principal Investigator: Alper Aykanat|
|Principal Investigator: Ercan Ayaz|
|Principal Investigator: Nursun Özcan|
|Principal Investigator:||Alper Aykanat||Hacettepe University|
|Principal Investigator:||Ercan Ayaz||Hacettepe University|
|Principal Investigator:||Nursun Özcan||Hacettepe University|