NCT04509375

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anemia of Prematurity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-14
• Primary completion: 2021-06-23
• Completion: 2021-06-23
• First posted: 2020-08-12
• Last updated: 2020-08-12

Locations

1 site across 1 country: Turkey (Türkiye)