Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries

This study aims to evaluate the diagnostic value of transcranial Doppler ultrasonography (TCD) for evaluating neonatal craniocerebral injuries.

Study Overview

• Status: Recruiting
• Conditions: Diagnostic Value; Transcranial Doppler Ultrasound; Neonatal Craniocerebral Injuries
• Intervention / Treatment: Device: Transcranial Doppler ultrasound

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

• Study Contact: Name: Neamat M Omar, MBBCH; Phone Number: 00201022433937; Email: neamatomar550@gmail.com

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Recruiting
      • Kafrelsheikh University
      • Contact: Neamat M Omar, MBBCH; Phone Number: 00201022433937; Email: neamatomar550@gmail.com
      • 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

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

How is the study designed?

Number of groups / cohorts

2

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	The sensitivity of transcranial Doppler ultrasound in diagnosing brain injury will be recorded	6 months post-procedure

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

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: Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Neurological; Radiography; Ultrasonography; Echoencephalography; Neuroradiography; Neuroimaging; Ultrasonography, Doppler; Ultrasonography, Doppler, Transcranial
• 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