Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities

Brain Abnormalities Clinical Trial

Official title:

Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities in Assuit University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05113108
• Other study ID #: Neonatal cranial Ultrasound
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: February 2023

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: Basma Fawzy, Resident doc
• Phone: 01062646952
• Email: basmafawzy80[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• To investigate the prevalence of cerebral abnormal findings in neonates admitted at nursery unit.{11}

• to identify the associated clinical features and to better target neonatal CUS investigations.{11}

Description:

Preterm birth is associated with various brain injuries. The earlier the period of gestation, more is the incidence of brain injuries. Brain injuries are known to be one of the most important factors leading to significant morbidity and mortality in these vulnerable preterm babies.{1} Cranial ultrasound (CUS) examinations have been performed on preterm infants to diagnose various perinatal brain injuries and for the prediction of long term outcomes.{2} Cranial ultrasonography (CUS) is the preferred modality to image the neonatal brain.{3} The advantages of CUS are numerous: it can be performed at the bedside with little disturbance to the infant, it is relatively safe, and can be repeated whenever needed, enabling visualization of ongoing brain maturation and the evolution of lesions.{4,5}

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• All neonates suspected clinically to be suffered from brain lesions at nursery unit at assiut university hospitals

Exclusion Criteria:

• Patients above the age of 28 days

Related Conditions & MeSH terms

• Brain Abnormalities
• Congenital Abnormalities

Intervention

Device:
• CUS
All neonates undergoing CUS at nursery unit at assiut university hospital. Cranial ultrasound is performed with basic grayscale imaging. For optimal resolution and good overview, a multifrequency (5-10 MHz) linear or convex sector transducer is used. Imaging is obtained through the anterior fontanel in the coronal and sagittal planes.{12,13} Typically, six to eight coronal images are obtained beginning at the frontal lobes just anterior to the frontal horns and extending to the occipital lobes posterior to the lateral ventricle trigones.{14} The transducer is then rotated 90°, and approximately five images are obtained, including a midline sagittal view of the corpus callosum and cerebellar vermis in addition to bilateral parasagittal images beginning in the midline and progressing laterally through the peripheral cortex.Doppler ultrasound may be added to assess ischemic areas.{13-15}

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basma Fawzy Abd Elhameed Ali

References & Publications (1)

Maalouf EF, Duggan PJ, Counsell SJ, Rutherford MA, Cowan F, Azzopardi D, Edwards AD. Comparison of findings on cranial ultrasound and magnetic resonance imaging in preterm infants. Pediatrics. 2001 Apr;107(4):719-27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the preavalence of cerebral abnormal findings in neonates	Cranial Ultrasound is performed with basic grayscale imaging	Baseline