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Neurological DisordersNCT06668233

Neurologocal Symptoms in CHD

An observational study of Neurological Disorders, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Neurological Disorders
What is being tested?
CT and CT scan
Type of treatment
Surgery or procedure
How many people
100 participants
Where
No sites listed yet
Study dates
Oct 2024to Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Children from 3 years to 18 years with congenital heart disease.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

zeinab salah Mahmoud, Bachelor of medicine contact

01144020179

zeinab97th@gmail.com

About this study

Official title: Neurocognitive Disorders in Children With Congenital Heart Disease

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

Read the detailed description

Congenital heart defects are significant structural abnormalities affecting the heart and major intrathoracic vessels. They are among the most common birth defects, constituting about one-third of all major congenital anomalies. Many of these defects necessitate surgical intervention during early childhood. Advances in surgical techniques have significantly improved survival rates for patients with congenital heart disease (CHD). However, a variety of systemic complications have become more apparent, including issues affecting the cardiac, pulmonary, gastrointestinal, neurological, and nephrological systems (Walaa El Naga et al., 2022).

Neurological complications greatly contribute to morbidity and mortality in pediatric CHD patients, significantly impacting their neurodevelopmental outcomes. Various studies indicate that up to 30% of children with congenital heart disease (CHD) experience neurological complications. Seizures are the most frequently reported neurological complication, accounting for approximately 70% of cases with neurological sequelae (Aly El Kazaz et al., 2022).

Also Neuropsychological studies of children with complex CHD reveal distinct deficits in intelligence, cognitive performance, executive function, language skills, visuospatial abilities, and attention. (Guo et al., 2021). Recognizing the long-term consequences of accumulated brain injury underscores the importance of identifying and minimizing early insults. (Le H.Sterling et al., 2021) The recognized neurodevelopmental challenges faced by children with CHD prompted the American Heart Association to recommend routine neurodevelopmental evaluations for high-risk patients with CHD. According to the American Heart Association, the initial visit, conducted before 12 months of age, should include a neuromotor examination assessing muscle tone, primitive and deep tendon reflexes, sensory status, and gross motor skills. Although many children with CHD now undergo these recommended neurological examinations, the examinations and their outcomes have not been thoroughly described. Additionally, factors predicting abnormal neurological examination results have not been identified. Enhancing our understanding of the findings from these routinely recommended evaluations will improve the detection of abnormalities, thereby optimizing support for children with CHD and their families.(Le Samantha butler et al., 2023).

Being tested
CT, CT scan
Medical subject headings
Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTRadiation

    CT Brain

  • CT scanRadiation

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

Study groups in NCT06668233
Study groupRoleWhat they receive
children from 3 years to 18 years with congenital heart diseaseNot described
Receives: Radiation: CT; Radiation: CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionOct 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06668233
Sponsor's protocol ID
neurologocal symptoms in CHD
Status last verified
Sep 2024
First submitted
22 Sep 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34921736

Questions about this trial

What is this clinical trial studying?

An observational study of Neurological Disorders, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact zeinab salah Mahmoud, Bachelor of medicine (01144020179, zeinab97th@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The aim of the study is to determine neurological and cognitive disorders in children with congenital heart disease for early diagnosis and treatment. (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06668233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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