Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries

NCT07322315 | Recruiting

• 1 other identifier: KFSIRB200-842
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diagnostic Value; Transcranial Doppler Ultrasound; Neonatal Craniocerebral Injuries

Outcome Measures

Primary Outcomes (1)

• Sensitivity of transcranial Doppler ultrasound

  The sensitivity of transcranial Doppler ultrasound in diagnosing brain injury will be recorded

  6 months post-procedure

Study Arms (2)

Group A

High-risk neonates with confirmed risk factor.

Device: Transcranial Doppler ultrasound

Group B

Healthy neonates without any identified risk factor, matched to Group A for age and sex.

Device: Transcranial Doppler ultrasound

Interventions

Transcranial Doppler ultrasound DEVICE

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 A; Group B

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Neamat M Omar, MBBCH

CONTACT

00201022433937; neamatomar550@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Diagnostic and Intervention Radiology, Faculty of Medicine, Kafr- Elsheikh University

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)