Transcranial Doppler ultrasound for diagnosing newborn brain injuries
Official title: Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries
Run by Kafrelsheikh University · NCT07322315 · Data updated 2026-11-12
This project will test whether bedside transcranial Doppler ultrasound can detect blood-flow problems in high-risk newborns with suspected brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 37 Weeks |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr ash Shaykh, Kafrelsheikh) |
| Status | Recruiting |
| Started | January 6, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT07322315 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are high-risk neonates (term or preterm) in the NICU with conditions such as neonatal sepsis, encephalopathy or hypoxic-ischemic injury, respiratory distress, seizures, low Apgar scores, low birth weight, or other signs suggesting central nervous system compromise.
✕Probably not a fit
Infants with major congenital malformations, known genetic metabolic diseases, severe intrauterine infection, or otherwise stable newborns who do not meet high-risk criteria are unlikely to gain benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will use transcranial Doppler ultrasonography (TCD) to record cerebral blood flow parameters in high-risk neonates admitted to a neonatal unit. TCD will be performed at the bedside, allowing repeated, time-resolved, noninvasive measurements without radiation or transport. Investigators will compare TCD findings with the infants' clinical signs (for example sepsis, encephalopathy, seizures, low Apgar scores) and routine diagnostic information to characterize diagnostic patterns. The study aims to describe how TCD signals correlate with neonatal craniocerebral injury and short-term clinical outcomes.
Why it matters
Potential benefit: If successful, TCD could provide a rapid, bedside, noninvasive way to identify neonatal cerebral blood-flow abnormalities and support earlier clinical decision-making.
How similar studies have gone: TCD is an established noninvasive method for monitoring cerebral blood flow and small neonatal studies have shown promising results, but larger validation for diagnostic use in neonatal brain injury is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, Egypt Recruiting
Study contacts
- Study coordinator: Neamat M Omar, MBBCH
- Email: neamatomar550@gmail.com
- Phone: 00201022433937
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.