Cerebral Blood Flow in Term and Preterm Neonates Using Doppler Ultrasonography

February 17, 2026 updated by: Sawsan Samy Aly Aly, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Term and Preterm Neonates

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Term Neonates
Normal Term neonates ≥ 37 weeks of gestational age
Preterm Neonates
Normal Preterm neonates < 37 weeks' gestational age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistive Index (RI)
Time Frame: Baseline
RI = (PSV - EDV)/PSV, indicates downstream resistance and the flexibility of cerebral vessels
Baseline
Pulsatility Index (PI)
Time Frame: Baseline
quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.
Baseline
Peak Systolic Velocity (PSV)
Time Frame: Baseline
represents blood flow during systole and reflects cardiac output
Baseline
End-Diastolic Velocity (EDV)
Time Frame: Baseline
EDV reflects diastolic flow and the resistance in the vessels
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Hisham Mostafa Kamel, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Doppler in Neonates

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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