Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities

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

• 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}

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Abnormalities
• Intervention / Treatment: Device: CUS

Detailed 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}

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Basma Fawzy, Resident doc; Phone Number: 01062646952; Email: basmafawzy80@gmail.com
• Study Contact Backup: Name: Sherif Mohamed, doctor; Phone Number: 01003691110; Email: sherifabdelal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates undergoing CUS at nursery unit at university hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the preavalence of cerebral abnormal findings in neonates	Cranial Ultrasound is performed with basic grayscale imaging	Baseline

Collaborators and Investigators

• Sponsor: Basma Fawzy Abd Elhameed Ali

Publications and helpful links

General Publications

• 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. doi: 10.1542/peds.107.4.719.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Neonatal cranial Ultrasound

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No