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NCT Number: NCT06668233

Neurologocal Symptoms in CHD

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

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT

Radiation

CT Brain

CT Scan

Radiation

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

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.

    Time frame: one year

Study contacts

Contact information is provided by the study sponsor or research team.

zeinab salah Mahmoud, Bachelor of medicine

CONTACT

[email protected]

01144020179

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Neurocognitive Disorders in Children With Congenital Heart Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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