Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries

January 7, 2026 updated by: Neamat Mohamed Kamal Omar, Kafrelsheikh University
This study aims to evaluate the diagnostic value of transcranial Doppler ultrasonography (TCD) for evaluating neonatal craniocerebral injuries.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A high-risk neonate refers to an infant, irrespective of gestational age or birth weight, who exhibits an elevated likelihood of experiencing health complications or death. Preterm infants, defined as those born alive at a gestational age of less than 37 weeks, have seen increased birth and survival rates due to advancements in medical technology and the widespread establishment of Neonatal Intensive Care Units (NICUs).

Neonatal sepsis is one of the leading causes of morbidity and mortality among term and preterm infants worldwide.

Transcranial Doppler ultrasonography (TCD) is the only noninvasive method that enables reliable evaluation of blood flow in the basal intracerebral vessels, providing physiological information complementary to anatomic imaging. TCD is relatively inexpensive, can be performed at the bedside, and enables monitoring in acute emergency settings and for prolonged periods with high temporal resolution, making it ideal for studying dynamic cerebrovascular responses.

Study Type

Observational

Enrollment (Estimated)

60

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 Locations

  • Egypt
    • Kafrelsheikh
      • Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516
        • Recruiting
        • Kafrelsheikh University
        • Contact:
        • Sub-Investigator:
          • Ahmed I Ebeid, MD
        • Sub-Investigator:
          • Haitham M Fouda, MD
        • Sub-Investigator:
          • Mahmoud A Ghalab, MD
        • Sub-Investigator:
          • Marwa A El-Degwi, MD

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

No

Sampling Method

Non-Probability Sample

Study Population

This prospective observational study will be carried out on 60 neonates admitted to Kafr- Elsheikh University Hospitals over a period of one year starting from approval of the Ethics Committee of Kafr- Elsheikh, Faculty of Medicine and parents of all the included patients will provide written informed consent.

Description

Inclusion Criteria:

  • Both sexes.

  • High-risk neonates with any of the following:

    • Critically ill neonates.
    • Neonatal sepsis.
    • Neonatal encephalopathy includes hypoxic-ischemic encephalopathy.
    • Respiratory distress.
    • Neonatal seizures.
    • Birth asphyxia.
    • Signs and or symptoms of central nervous system disorders like microcephaly, macrocephaly, hypotonia, unexplained poor feeding,
    • Neonates born out of traumatic/instrumental labor.
    • Suspected metabolic disturbances.
    • Neonates with low APGAR score (<7).
    • Neonates with low birth weight (<2.5 kg).

Exclusion Criteria:

  • Congenital malformations.
  • Genetic metabolic diseases or other severe complications.
  • Severe intrauterine infection.

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
Intervention / Treatment
Group A
High-risk neonates with confirmed risk factor.
Device: Transcranial Doppler ultrasound
Trans-cranial ultrasound will be carried out for assessment of blood flow velocity in the anterior [ACA] and middle cerebral arteries [MCA] using duplex pulsed Doppler ultrasound.
Group B
Healthy neonates without any identified risk factor, matched to Group A for age and sex.
Device: Transcranial Doppler ultrasound
Trans-cranial ultrasound will be carried out for assessment of blood flow velocity in the anterior [ACA] and middle cerebral arteries [MCA] using duplex pulsed Doppler ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of transcranial Doppler ultrasound
Time Frame: 6 months post-procedure
The sensitivity of transcranial Doppler ultrasound in diagnosing brain injury will be recorded
6 months post-procedure

Collaborators and Investigators

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

Sponsor

Kafrelsheikh University

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 (Actual)

January 6, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Estimated)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSIRB200-842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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