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Not yet recruitingNCT07427342Updated Feb 23, 2026

Cerebral Blood Flow in Term and Preterm Neonates Using Doppler Ultrasonography

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

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
1 Hour to 48 Hours
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Cerebral Blood Flow

Keywords

  • Cerebral Blood Flow
  • Doppler Ultrasonography
  • Term and Preterm Neonates
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In context

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Hour to 48 Hours
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Term and Preterm Neonates

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Term Neonates

    Normal Term neonates ≥ 37 weeks of gestational age

  • Preterm Neonates

    Normal Preterm neonates \< 37 weeks' gestational age

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What researchers measure

Primary outcomes

  1. Resistive Index (RI)

    RI = (PSV - EDV)/PSV, indicates downstream resistance and the flexibility of cerebral vessels

    Time frame: Baseline

  2. Pulsatility Index (PI)

    quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.

    Time frame: Baseline

  3. Peak Systolic Velocity (PSV)

    represents blood flow during systole and reflects cardiac output

    Time frame: Baseline

  4. End-Diastolic Velocity (EDV)

    EDV reflects diastolic flow and the resistance in the vessels

    Time frame: Baseline

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Study locations

1 site
  • Assiut university
    Asyut, Egypt
08

References and documents

Publications

  • 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 18289437 ↗
  • Naqvi J, Yap KH, Ahmad G, Ghosh J. Transcranial Doppler ultrasound: a review of the physical principles and major applications in critical care. Int J Vasc Med. 2013;2013:629378. doi: 10.1155/2013/629378. Epub 2013 Dec 12. PubMed 24455270 ↗
  • Fichera G, Stramare R, Bisogno G, Wyttenbach R, Goeggel BS, Del Grande F, Giraudo C, Lacalamita MC. Neonatal cerebral ultrasound: anatomical variants and age-related diseases. J Ultrasound. 2024 Dec;27(4):993-1002. doi: 10.1007/s40477-024-00914-8. Epub 2024 Jun 25. PubMed 38918318 ↗
  • Lu Q, Lu YJ, Chen ZH, Cao CY, Wu W. Predictive value of transcranial Doppler ultrasound for brain development and craniocerebral injury in premature infants. Am J Transl Res. 2025 Mar 15;17(3):2076-2082. doi: 10.62347/QJZN6645. eCollection 2025. PubMed 40225994 ↗
  • Farag MM, Gouda MH, Almohsen AMA, Khalifa MA. Intraventricular hemorrhage prediction in premature neonates in the era of hemodynamics monitoring: a prospective cohort study. Eur J Pediatr. 2022 Dec;181(12):4067-4077. doi: 10.1007/s00431-022-04630-5. Epub 2022 Sep 28. PubMed 36171508 ↗
  • Kamel SM, Badr-Eldin RM, Arafat MM, Hashem RH. Role of transcranial Doppler in assessment of cerebral blood flow in full term neonates with extreme unconjugated hyperbilirubinemia. J Ultrasound. 2023 Mar;26(1):175-184. doi: 10.1007/s40477-022-00704-0. Epub 2022 Aug 15. PubMed 35969370 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07427342
Lead sponsor
Assiut University
Responsible party
Sawsan Samy Aly Aly (Resident doctor, Assiut University) — Principal investigator
First posted
Feb 23, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Apr 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Feb 23, 2026

Study contacts

Sawsan Samy Aly Aly
Contact
Sawsan.15235540@med.aun.edu.eg
01159860374
Mostafa Ahmed Sayed, Lecturer
Contact
most.rad@aun.edu.eg
Hisham Mostafa Kamel, Professor
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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