NCT06668233

Brief Summary

The aim of the study is to determine neurological and cognitive disorders in children with congenital heart disease for early diagnosis and treatment

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 Oct 2024

Status
not yet recruiting

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

September 22, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 31, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 22, 2024

Last Update Submit

October 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The aim of the study is to determine neurological and cognitive disorders in children with congenital heart disease for early diagnosis and treatment.

    one year

Study Arms (1)

children from 3 years to 18 years with congenital heart disease

Radiation: CTRadiation: CT scan

Interventions

CTRADIATION

CT Brain

children from 3 years to 18 years with congenital heart disease
CT scanRADIATION

Neuroimaging in case with delayed development , focal neurological symptoms or seziures

children from 3 years to 18 years with congenital heart disease

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children from 3 years to 18 years with congenital heart disease.

You may qualify if:

  • \- Children from 3 years to 18 years with congenital heart disease

You may not qualify if:

  • New born infants. Children with normal heart. Children with chromosomal or metabolic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Butler SC, Sadhwani A, Rofeberg V, Cassidy AR, Singer J, Calderon J, Wypij D, Newburger JW, Rollins CK; Cardiac Neurodevelopmental Program at Boston Children's Hospital Group. Neurological features in infants with congenital heart disease. Dev Med Child Neurol. 2022 Jun;64(6):762-770. doi: 10.1111/dmcn.15128. Epub 2021 Dec 18.

    PMID: 34921736BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases

Central Study Contacts

zeinab salah Mahmoud, Bachelor of medicine

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 22, 2024

First Posted

October 31, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

October 31, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share