An observational study in Cerebral Blood Flow, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Hour to 48 Hours. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Assiut University · Observational
This study aims to evaluate cerebral blood flow in stable term and preterm newborns using Doppler ultrasonography. By measuring and comparing PSV, EDV, RI, and PI in the main brain arteries, the study seeks to identify normal physiological differences in cerebral perfusion across different gestational ages. The main goal is to establish reference values that can guide clinical monitoring, allow early detection of blood flow problems, and improve neuroprotective care in newborns.
The brain is a very active organ that needs a constant and well-controlled blood flow to provide oxygen and nutrients for normal brain function, growth, and development. In newborns, ensuring proper blood flow to the brain is especially important to support fast brain growth and prevent damage. Even small changes in cerebral blood flow can lead to serious problems, such as bleeding inside the brain, lack of oxygen-related injury, or long-term developmental delays. This risk is higher in preterm infants, whose ability to regulate brain blood flow is not fully developed and whose blood vessels are fragile. Therefore, accurately checking cerebral blood flow is crucial for monitoring brain health in newborns and for planning timely medical care.
Term and preterm newborns show clear differences in brain blood vessel function. In term infants, the brain's blood flow regulation is fairly mature, allowing vessels to change their size in response to blood pressure and metabolic needs, which helps keep blood flow stable. Preterm infants, especially those born before 32 weeks of gestation, have underdeveloped and often unstable regulation of cerebral blood flow. Their brain blood vessels rely heavily on blood pressure, making them more likely to suffer from reduced blood flow during low blood pressure or bleeding during high blood flow. These physiological differences highlight the importance of studying cerebral blood flow patterns at different gestational ages.
The preterm brain is not fully developed, both structurally and functionally. It has immature myelination, thin-walled blood vessels, and high energy needs. Any disruption in cerebral blood flow can quickly cause nerve cell injury, white matter damage, and long-term developmental problems. Medical conditions such as patent ductus arteriosus, respiratory distress, anemia, and sepsis can further affect brain blood flow.
Therefore, reliable monitoring methods are essential to detect early changes in blood flow and to guide protective care for the developing brain in these vulnerable infants.
Doppler ultrasonography is a safe, non-invasive bedside tool for assessing brain blood flow in newborns. Using the anterior fontanelle and temporal approach as a window provides real-time measurements of blood flow speeds in the main brain vessels (anterior, middle cerebral artery), which have therefore been the primary focus of most neonatal Doppler studies. Unlike MRI or CT, Doppler Ultrasonography does not require sedation or expose infants to radiation, which makes it suitable for repeated examinations. This technique is especially useful for preterm infants, as frequent monitoring is important to identify early abnormalities in brain circulation.
Key Doppler measurements include Peak Systolic Velocity (PSV), End-Diastolic Velocity (EDV), the Resistive Index (RI = (PSV - EDV)/PSV), and Pulsatility Index (PI= (PSV - EDV)/ Time Averaged Mean Velocity (TAMV)). PSV represents blood flow during systole and reflects cardiac output, EDV reflects diastolic flow and the resistance in the vessels, and RI indicates downstream resistance and the flexibility of cerebral vessels. PI quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.
Preterm infants usually have higher RI and lower EDV, indicating immature vessel tone and increased resistance. Comparing these values between term and preterm newborns provides important information about developmental differences in brain blood flow.
Although assessing cerebral blood flow is clinically important, reported Doppler measurements vary widely between studies. Factors such as gestational age, birth weight, clinical condition, machine settings, angle of measurement, and examiner experience all contribute to these differences. Many earlier studies included medically unstable newborns, making interpretation more difficult. Therefore, well-designed and standardized studies are needed to establish reliable reference values and to support accurate clinical decisions and decrease comorbidity.
Assessing cerebral blood flow in both term and preterm newborns provides important information about normal brain development and helps distinguish between normal maturation and abnormal changes. Establishing reference values for Doppler measurements allows early detection of problems in brain circulation and supports timely interventions to protect neurodevelopment, especially in preterm infants.
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Term and Preterm Neonates
Exclusion Criteria:
Normal Term neonates ≥ 37 weeks of gestational age
Normal Preterm neonates \< 37 weeks' gestational age
Resistive Index (RI)
RI = (PSV - EDV)/PSV, indicates downstream resistance and the flexibility of cerebral vessels
Time frame: Baseline
Pulsatility Index (PI)
quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.
Time frame: Baseline
Peak Systolic Velocity (PSV)
represents blood flow during systole and reflects cardiac output
Time frame: Baseline
End-Diastolic Velocity (EDV)
EDV reflects diastolic flow and the resistance in the vessels
Time frame: Baseline
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Assiut University