NCT05113108

Brief 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}

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

October 28, 2021

Last Update Submit

November 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Investigate the preavalence of cerebral abnormal findings in neonates

    Cranial Ultrasound is performed with basic grayscale imaging

    Baseline

Interventions

CUSDEVICE

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}

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates undergoing CUS at nursery unit at university hospital

You may qualify if:

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

You may not qualify if:

  • Patients above the age of 28 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1542/peds.107.4.719.

    PMID: 11335750BACKGROUND

Central Study Contacts

Basma Fawzy, Resident doc

CONTACT

Sherif Mohamed, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 9, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

November 29, 2021

Record last verified: 2021-11