Actively Recruiting

Age: 0 - 37Weeks
All Genders
ID07322315

Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries

Led by Kafrelsheikh University · Updated on 2026-01-08

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of transcranial Doppler ultrasonography (TCD) to diagnose brain injuries in newborns, especially those considered high-risk. High-risk neonates include infants with conditions such as neonatal sepsis, encephalopathy, respiratory distress, seizures, birth asphyxia, or other signs of central nervous system disorders. This observational study focuses on newborns up to 37 weeks old and aims to understand how well TCD can detect craniocerebral injuries in these vulnerable infants. The study involves two groups: high-risk neonates with confirmed risk factors and healthy neonates matched by age and sex. Participants will undergo transcranial Doppler ultrasound, a noninvasive procedure performed at the bedside that measures blood flow velocity in key brain arteries. This device-based assessment provides real-time information about cerebral blood flow, complementing other imaging methods. The study will compare findings between high-risk and healthy neonates. During the study, participants will be monitored, and the primary outcome is the sensitivity of the transcranial Doppler ultrasound measured six months after the procedure. Researchers will observe and record blood flow data using duplex pulsed Doppler ultrasound. The study includes careful evaluation of the infants' neurological status and clinical conditions. The total participation duration and follow-up details are aligned with the timing of the primary outcome measurement at six months post-assessment.

CONDITIONS

Brief Title

Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries

Who Can Participate

Age: 0 - 37Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Both sexes
  • High-risk neonates with any of the following: critically ill neonates, neonatal sepsis, neonatal encephalopathy including hypoxic-ischemic encephalopathy, respiratory distress, neonatal seizures, birth asphyxia
  • Signs or symptoms of central nervous system disorders such as microcephaly, macrocephaly, hypotonia, unexplained poor feeding
  • Neonates born from traumatic or instrumental labor
  • Suspected metabolic disturbances
  • Neonates with low APGAR score (<7)
  • Neonates with low birth weight (<2.5 kg)
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day procedure

Participants undergo transcranial Doppler ultrasound to assess blood flow velocity in the anterior and middle cerebral arteries using duplex pulsed Doppler ultrasound.

1 visit (in-person)

Long-term Monitoring

Duration - 6 months

Participants are monitored for up to 6 months post-procedure to evaluate the diagnostic sensitivity of transcranial Doppler ultrasound.

Follow-up visits as needed over 6 months

Trial Site Locations

Total: 1 location

1

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516

Actively Recruiting

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Research Team

N

Neamat M Omar, MBBCH

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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