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Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities

NCT ID: NCT05113108

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-02-28

Brief Summary

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* 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}

Detailed Description

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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}

Conditions

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Brain Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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}

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Basma Fawzy Abd Elhameed Ali

OTHER

Sponsor Role lead

Responsible Party

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Basma Fawzy Abd Elhameed Ali

Resident Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Basma Fawzy, Resident doc

Role: CONTACT

Phone: 01062646952

Email: [email protected]

Sherif Mohamed, doctor

Role: CONTACT

Phone: 01003691110

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 11335750 (View on PubMed)

Other Identifiers

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Neonatal cranial Ultrasound

Identifier Type: -

Identifier Source: org_study_id