Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries

Kafrelsheikh University

Status: Enrolling

Conditions: Diagnostic Value; Neonatal Craniocerebral Injuries; Transcranial Doppler Ultrasound

Treatments: Device: Transcranial Doppler ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT07322315

KFSIRB200-842

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Group A

Description:

High-risk neonates with confirmed risk factor.

Treatment:

Device: Transcranial Doppler ultrasound

Group B

Description:

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

Treatment:

Device: Transcranial Doppler ultrasound