Neurologocal Symptoms in CHD

NCT ID: NCT06668233

Last Updated: 2024-10-31

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

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-11-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Neurological Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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children from 3 years to 18 years with congenital heart disease

CT

Intervention Type RADIATION

CT Brain

CT scan

Intervention Type RADIATION

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

Interventions

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CT

CT Brain

Intervention Type RADIATION

CT scan

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* New born infants. Children with normal heart. Children with chromosomal or metabolic disease.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Zeinab Salah Mahmoud Ahmed

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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zeinab salah Mahmoud, Bachelor of medicine

Role: CONTACT

Phone: 01144020179

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 34921736 (View on PubMed)

Other Identifiers

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neurologocal symptoms in CHD

Identifier Type: -

Identifier Source: org_study_id