Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries

NCT ID: NCT07322315

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-06

Study Completion Date

2026-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diagnostic Value Transcranial Doppler Ultrasound Neonatal Craniocerebral Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

High-risk neonates with confirmed risk factor.

Transcranial Doppler ultrasound

Intervention Type 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 B

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

Transcranial Doppler ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Neamat Mohamed Kamal Omar

Resident of Diagnostic and Intervention Radiology, Faculty of Medicine, Kafr- Elsheikh University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Neamat M Omar, MBBCH

Role: CONTACT

00201022433937

Facility Contacts

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Neamat M Omar, MBBCH

Role: primary

00201022433937

Other Identifiers

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KFSIRB200-842

Identifier Type: -

Identifier Source: org_study_id

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