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Набор скоро начнётся NCT07427342

Cerebral Blood Flow in Term and Preterm Neonates Using Doppler Ultrasonography

Наблюдательное Cerebral Blood Flow

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cerebral Blood Flow. Базовые параметры: 1 Hour — 48 Hours · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparative Analysis of Cerebral Blood Flow in Term and Preterm Neonates Using Doppler Ultrasonography

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Resistive Index (RI) [Срок оценки: Baseline]
  • Pulsatility Index (PI) [Срок оценки: Baseline]
  • Peak Systolic Velocity (PSV) [Срок оценки: Baseline]
  • End-Diastolic Velocity (EDV) [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Term neonates ≥ 37 weeks of gestational age.
  • Preterm neonates < 37 weeks' gestational age.
  • Hemodynamically stable infants at the time of examination.
  • Parental/guardian informed consent obtained.
  • Within the first 48 hours after birth.
  • Birth weight appreciate for gestational age.

Критерии исключения

  • Infants aged more than 48 hours after birth.
  • Neonates with major congenital anomalies (cardiac, neurological, or craniofacial).
  • Suspected or confirmed intracranial hemorrhage or brain malformations, such as intraventricular hemorrhage, may influence RI measurements and interfere with accurate assessment of cerebral blood flow.
  • Neonates requiring inotropic support at the time of scan.
  • Neonates with severe respiratory instability or mechanical ventilation (unless included intentionally).
  • Infants with sepsis or metabolic derangements affecting cerebral perfusion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Египет · 1 центр
  • Assiut university — Asyut

Публикации

  • M. F. A. Ali, "Transcranial Doppler ultrasonography ( uses , limitations , and potentials ): a review article," 2021.
  • M. Ramadan, E. Kholy, and I. M. A. El-dayem, "Neonatal Hypoxic Ischemic Encephalopathy : Early Diagnosis and Outcome Prediction with Ultrasound," vol. 101, no. April 2024, pp. 5520-5526, 2025.
  • Camfferman FA, de Goederen R, Govaert P, Dudink J, van Bel F, Pellicer A, Cools F; eurUS.brain group. Diagnostic and predictive value of Doppler ultrasound for evaluation of the brain circulation in preterm infants: a systematic review. Pediatr Res. 2020 Mar;87(Suppl 1):50-58. doi: 10.1038/s41390-020-0777-x. PMID 32218536
  • Vinci F, Tiseo M, Colosimo D, Calandrino A, Ramenghi LA, Biasucci DG. Point-of-care brain ultrasound and transcranial doppler or color-coded doppler in critically ill neonates and children. Eur J Pediatr. 2024 Mar;183(3):1059-1072. doi: 10.1007/s00431-023-05388-0. Epub 2023 Dec 19. PMID 38112802
  • Bleton H, Perera S, Sejdic E. Cognitive tasks and cerebral blood flow through anterior cerebral arteries: a study via functional transcranial Doppler ultrasound recordings. BMC Med Imaging. 2016 Mar 12;16:22. doi: 10.1186/s12880-016-0125-0. PMID 26969112
  • Pan Y, Wan W, Xiang M, Guan Y. Transcranial Doppler Ultrasonography as a Diagnostic Tool for Cerebrovascular Disorders. Front Hum Neurosci. 2022 Apr 29;16:841809. doi: 10.3389/fnhum.2022.841809. eCollection 2022. PMID 35572008
  • Jarmund AH, Pedersen SA, Torp H, Dudink J, Nyrnes SA. A Scoping Review of Cerebral Doppler Arterial Waveforms in Infants. Ultrasound Med Biol. 2023 Apr;49(4):919-936. doi: 10.1016/j.ultrasmedbio.2022.12.007. Epub 2023 Jan 31. PMID 36732150
  • Rasulo FA, De Peri E, Lavinio A. Transcranial Doppler ultrasonography in intensive care. Eur J Anaesthesiol Suppl. 2008;42:167-73. doi: 10.1017/S0265021507003341. PMID 18289437

Идентификаторы

NCT: NCT07427342 · Doppler in Neonates

Первоисточники (государственные реестры)

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