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NCT Number: NCT07322315

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.

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Key information

Age range

Up to 37 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location status: Recruiting

Location contact

Ahmed I Ebeid, MD

SUB_INVESTIGATOR

Haitham M Fouda, MD

SUB_INVESTIGATOR

Mahmoud A Ghalab, MD

SUB_INVESTIGATOR

Marwa A El-Degwi, MD

SUB_INVESTIGATOR

Neamat M Omar, MBBCH

CONTACT

[email protected]

00201022433937

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Sensitivity of transcranial Doppler ultrasound

    Time frame: 6 months post-procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Neamat M Omar, MBBCH

CONTACT

[email protected]

00201022433937

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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